Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction
PARAGON-HF
A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients (NYHA Class II-IV) With Preserved Ejection Fraction (PARAGON-HF)
2 other identifiers
interventional
4,822
40 countries
677
Brief Summary
The purpose of this study was to evaluate the effect of LCZ696 compared to valsartan in the reduction of cardiovascular death and heart failure(HF) hospitalizations in patients with HF with preserved ejection fraction.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2014
Longer than P75 for phase_3
677 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 8, 2013
CompletedFirst Posted
Study publicly available on registry
August 12, 2013
CompletedStudy Start
First participant enrolled
July 18, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 7, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 7, 2019
CompletedResults Posted
Study results publicly available
September 29, 2020
CompletedSeptember 29, 2020
September 1, 2020
4.9 years
August 8, 2013
May 29, 2020
September 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cumulative Number of Primary Composite Events of Cardiovascular (CV) Death and Total (First and Recurrent) HF Hospitalizations.
The primary objective of this study is to compare LCZ696 to valsartan in reducing the rate of the composite endpoint of CV death and total (first and recurrent) HF hospitalizations, in HF patients (New York Heart Association \[NYHA\] Class II-IV) with preserved ejection fraction (left ventricular ejection fraction \[LVEF\] ≥45%). The treatment arm with the lower rate of events will be deemed as having a successful response.
Total follow up time (up to 57 months)
Secondary Outcomes (4)
Change in the Clinical Summary Score From Baseline to Month 8 by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Baseline, 8 months
Change From Baseline to Month 8 in New York Heart Association (NYHA) Functional Class
Baseline, 8 months
Participants With First Occurrence of a Composite Renal Endpoint
Randomization to total follow-up time (up to 57 months)
All-cause Mortality
Randomization to total follow up time (up to 57 months)
Study Arms (2)
LCZ696
EXPERIMENTALSingle Blind Run-in Period (3-8 weeks): Patients will start on Valsartan 80 mg b.i.d. for 1-2 weeks followed by LCZ696 100 mg b.i.d. for 2-4 weeks prior to randomization into the Double Blind period (up to 57 months). Patients can only be randomized from the run-in period if they meet all of the run-in safety criteria. Target dose of LCZ696 during the double blind period is 200 mg b.i.d.
Valsartan
ACTIVE COMPARATORSingle Blind Run-in Period (3-8 weeks): Patients will start on Valsartan 80 mg b.i.d. for 1-2 weeks followed by LCZ696 100 mg b.i.d. for 2-4 weeks prior to randomization into the Double Blind period (up to 57 months). Patients can only be randomized from the run-in period if they meet all of the run-in safety criteria. Target dose of Valsartan during the double blind period is 160 mg b.i.d.
Interventions
Eligibility Criteria
You may qualify if:
- Left ventricular ejection fraction (LVEF) ≥45% by echo during screening epoch or within 6 months prior to study entry.
- Symptom(s) of heart failure (HF) and requiring treatment with diuretic(s) for HF at least 30 days prior to study entry.
- Current symptom(s) of HF (NYHA class II-IV)
- Structural heart disease (left atrial enlargement or left ventricular hypertrophy) documented by echocardiogram.
- Elevated NT-proBNP
You may not qualify if:
- Any prior measurement of LVEF \< 40%.
- Acute coronary syndrome (including MI), cardiac surgery, other major CV surgery within 3 months , or urgent percutaneous coronary intervention within 3 months or and elective PCI within 30 days prior to entry.
- Any clinical event within the 6 months prior to entry could have reduced the LVEF (e.g., MI, CABG), unless an echo measurement performed after the event confirms a LVEF ≥45%.
- Current acute decompensated HF requiring therapy.
- Patients who require treatment with 2 or more of the following: an angiotensin converting enzyme inhibitor (ACEI), an angiotensin receptor blocker (ARB) or a renin inhibitor.
- Alternative reason for shortness of breath such as: significant pulmonary disease or severe COPD, hemoglobin (Hgb) \<10 g/dl, or body mass index (BMI) \> 40 kg/m2.
- Systolic blood pressure (SBP) ≥ 180 mmHg at entry, or SBP \>150 mmHg and \<180 mmHg at entry unless the patient is receiving 3 or more antihypertensive drugs, or SBP \< 110 mmHg at entry.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (715)
Novartis Investigative Site
Huntsville, Alabama, 35801, United States
Novartis Investigative Site
Mobile, Alabama, 36608, United States
Novartis Investigative Site
Muscle Shoals, Alabama, 35662, United States
Novartis Investigative Site
Little Rock, Arkansas, 72204, United States
Novartis Investigative Site
Beverly Hills, California, 90211, United States
Novartis Investigative Site
Los Angeles, California, 90073, United States
Novartis Investigative Site
Northridge, California, 91325, United States
Novartis Investigative Site
Orange, California, 92868, United States
Novartis Investigative Site
San Diego, California, 92161, United States
Novartis Investigative Site
Santa Ana, California, 92704, United States
Novartis Investigative Site
Denver, Colorado, 80220, United States
Novartis Investigative Site
Hartford, Connecticut, 06105, United States
Novartis Investigative Site
New Haven, Connecticut, 06520-8062, United States
Novartis Investigative Site
Stamford, Connecticut, 06905, United States
Novartis Investigative Site
West Haven, Connecticut, 06516, United States
Novartis Investigative Site
Bradenton, Florida, 34209, United States
Novartis Investigative Site
Gainesville, Florida, 32608, United States
Novartis Investigative Site
Lake Worth, Florida, 33461, United States
Novartis Investigative Site
Miami, Florida, 33143, United States
Novartis Investigative Site
Tallahassee, Florida, 32308, United States
Novartis Investigative Site
Atlanta, Georgia, 30309, United States
Novartis Investigative Site
Atlanta, Georgia, 30310-1495, United States
Novartis Investigative Site
Covington, Georgia, 30014, United States
Novartis Investigative Site
Cumming, Georgia, 30041, United States
Novartis Investigative Site
Chicago, Illinois, 60611, United States
Novartis Investigative Site
Chicago, Illinois, 60637, United States
Novartis Investigative Site
Evanston, Illinois, 60201, United States
Novartis Investigative Site
Hazel Crest, Illinois, 60429, United States
Novartis Investigative Site
Lombard, Illinois, 60148, United States
Novartis Investigative Site
Maywood, Illinois, 60153, United States
Novartis Investigative Site
Oakbrook Terrace, Illinois, 60181, United States
Novartis Investigative Site
Peoria, Illinois, 61602, United States
Novartis Investigative Site
Quincy, Illinois, 62301, United States
Novartis Investigative Site
Louisville, Kentucky, 40206, United States
Novartis Investigative Site
Baton Rouge, Louisiana, 70808, United States
Novartis Investigative Site
Hammond, Louisiana, 70403, United States
Novartis Investigative Site
Lafayette, Louisiana, 70508, United States
Novartis Investigative Site
Slidell, Louisiana, 70458, United States
Novartis Investigative Site
Biddeford, Maine, 04005, United States
Novartis Investigative Site
Portland, Maine, 04102, United States
Novartis Investigative Site
Baltimore, Maryland, 21229, United States
Novartis Investigative Site
Baltimore, Maryland, 21287, United States
Novartis Investigative Site
Columbia, Maryland, 21044, United States
Novartis Investigative Site
Boston, Massachusetts, 02118, United States
Novartis Investigative Site
Boston, Massachusetts, United States
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Ann Arbor, Michigan, 48105, United States
Novartis Investigative Site
Detroit, Michigan, 48202, United States
Novartis Investigative Site
Grand Blanc, Michigan, 48439, United States
Novartis Investigative Site
Saginaw, Michigan, 48601, United States
Novartis Investigative Site
Minneapolis, Minnesota, 55417, United States
Novartis Investigative Site
Minneapolis, Minnesota, 55433, United States
Novartis Investigative Site
Minneapolis, Minnesota, 55455, United States
Novartis Investigative Site
Saint Cloud, Minnesota, 56303, United States
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Saint Paul, Minnesota, 55102, United States
Novartis Investigative Site
Belzoni, Mississippi, 39038, United States
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Jackson, Mississippi, 39216, United States
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St Louis, Missouri, 63110, United States
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St Louis, Missouri, 63136, United States
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Kalispell, Montana, 59901 3158, United States
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Lincoln, Nebraska, 68506, United States
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Lebanon, New Hampshire, 03756, United States
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Morristown, New Jersey, 07960, United States
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New Brunswick, New Jersey, 08901, United States
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Ridgewood, New Jersey, 07450, United States
Novartis Investigative Site
Albuquerque, New Mexico, 87102, United States
Novartis Investigative Site
Brooklyn, New York, 11215, United States
Novartis Investigative Site
Buffalo, New York, 14203, United States
Novartis Investigative Site
Buffalo, New York, 14215, United States
Novartis Investigative Site
Flushing, New York, 11355, United States
Novartis Investigative Site
Kingston, New York, 12401, United States
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Northport, New York, 11768, United States
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Rochester, New York, 14642, United States
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Saratoga Springs, New York, 12866, United States
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The Bronx, New York, 10467, United States
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Chapel Hill, North Carolina, 27599-7075, United States
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Winston-Salem, North Carolina, 27157, United States
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Grand Forks, North Dakota, 58201, United States
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Canton, Ohio, 44710, United States
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Marion, Ohio, 43302, United States
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Tulsa, Oklahoma, 74133, United States
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Portland, Oregon, 97225, United States
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Philadelphia, Pennsylvania, 19107, United States
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Yardley, Pennsylvania, 19067, United States
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Providence, Rhode Island, 02908, United States
Novartis Investigative Site
Warwick, Rhode Island, 02886, United States
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Charleston, South Carolina, 29403, United States
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Rapid City, South Dakota, 57701, United States
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Sioux Falls, South Dakota, 57104, United States
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Knoxville, Tennessee, 37917, United States
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Memphis, Tennessee, 38104, United States
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Nashville, Tennessee, 37203, United States
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Nashville, Tennessee, 37212, United States
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Beaumont, Texas, 77702, United States
Novartis Investigative Site
Dallas, Texas, 75216, United States
Novartis Investigative Site
Dallas, Texas, 75231, United States
Novartis Investigative Site
Dallas, Texas, 75235, United States
Novartis Investigative Site
Houston, Texas, 77030, United States
Novartis Investigative Site
Houston, Texas, 77094, United States
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Livingston, Texas, 77351, United States
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McKinney, Texas, 75069, United States
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San Antonio, Texas, 78234, United States
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Tomball, Texas, 77375, United States
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Salt Lake City, Utah, 84124, United States
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Salt Lake City, Utah, 84132, United States
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White River Junction, Vermont, 05009, United States
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Seattle, Washington, 98122, United States
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Seattle, Washington, 98195, United States
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Madison, Wisconsin, 53705, United States
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Madison, Wisconsin, 53792-1615, United States
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Milwaukee, Wisconsin, 53215, United States
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CABA, Buenos Aires, 1407, Argentina
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CABA, Buenos Aires, C1056ABJ, Argentina
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Caba, Buenos Aires, C1280AEB, Argentina
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Quilmes, Buenos Aires, B1878GEG, Argentina
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Ramos Mejía, Buenos Aires, B1704ETD, Argentina
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CABA, Buenos Aires F.D., C1179AAB, Argentina
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Posadas, Misiones Province, N3300AHX, Argentina
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Salta, Salta Province, A4406BPF, Argentina
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San Miguel de Tucumán, San Miguel de Tucuman, T4000ICL, Argentina
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Rosario, Santa Fe Province, 2000, Argentina
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Rosario, Santa Fe Province, 3080, Argentina
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Rosario, Santa Fe Province, S2000DSV, Argentina
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Rosario, Santa Fe Province, S2000QID, Argentina
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San Miguel de Tucumán, Tucumán Province, T4000IFL, Argentina
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Buenos Aires, C1425AGP, Argentina
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Buenos Aires, C1428DCO, Argentina
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CABA, C1119ACN, Argentina
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Córdoba, X5000AAX, Argentina
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Córdoba, X5000EVQ, Argentina
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Córdoba, X5009BSN, Argentina
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Córdoba, X5016KET, Argentina
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Córdoba, X5022CPU, Argentina
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Formosa, P3600, Argentina
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San Luis, D5702JRS, Argentina
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Santa Fe, S3000FWO, Argentina
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Southport, Queensland, 4215, Australia
Novartis Investigative Site
Bedford Park, South Australia, 5041, Australia
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Bundoora, Victoria, 3083, Australia
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Epping, Victoria, 3076, Australia
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Geelong, Victoria, 3220, Australia
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Innsbruck, Tyrol, 6020, Austria
Novartis Investigative Site
Braunau am Inn, A5280, Austria
Novartis Investigative Site
Graz, 8020, Austria
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Graz, A-8036, Austria
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Grossgmain, 5084, Austria
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Linz, 4010, Austria
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Vienna, 1130, Austria
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Vienna, A 1090, Austria
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Aalst, 9300, Belgium
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Antwerp, 2060, Belgium
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Brasschaat, 2930, Belgium
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Brussels, 1200, Belgium
Novartis Investigative Site
De Pinte, 9840, Belgium
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Genk, 3600, Belgium
Novartis Investigative Site
Ghent, 9000, Belgium
Novartis Investigative Site
Hasselt, 3500, Belgium
Novartis Investigative Site
Huy, 4500, Belgium
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Kortrijk, 8500, Belgium
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Leuven, 3000, Belgium
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Ottignies, 1340, Belgium
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Goiânia, Goiás, 74605-020, Brazil
Novartis Investigative Site
Belo Horizonte, Minas Gerais, 30150-221, Brazil
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Uberlândia, Minas Gerais, 38411 186, Brazil
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Campina Grande do Sul, Paraná, 83430-000, Brazil
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Curitiba, Paraná, 80730 150, Brazil
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Porto Alegre, Rio Grande do Sul, 90035-003, Brazil
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Porto Alegre, Rio Grande do Sul, 90880-480, Brazil
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Blumenau, Santa Catarina, 89020 430, Brazil
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Campinas, São Paulo, 13020-431, Brazil
Novartis Investigative Site
Campinas, São Paulo, 13060-904, Brazil
Novartis Investigative Site
Liberdade, São Paulo, 01504-001, Brazil
Novartis Investigative Site
Ribeirão Preto, São Paulo, 14055-370, Brazil
Novartis Investigative Site
São José do Rio Preto, São Paulo, 15090 000, Brazil
Novartis Investigative Site
São Paulo, São Paulo, 08270-070, Brazil
Novartis Investigative Site
Smolyan, Bulgaria, 4700, Bulgaria
Novartis Investigative Site
Burgas, 8127, Bulgaria
Novartis Investigative Site
Pazardzhik, 4400, Bulgaria
Novartis Investigative Site
Pleven, 5800, Bulgaria
Novartis Investigative Site
Plovdiv, 4000, Bulgaria
Novartis Investigative Site
Plovdiv, 4002, Bulgaria
Novartis Investigative Site
Shumen, 9700, Bulgaria
Novartis Investigative Site
Silistra, 7500, Bulgaria
Novartis Investigative Site
Sliven, 8800, Bulgaria
Novartis Investigative Site
Sofia, 1000, Bulgaria
Novartis Investigative Site
Sofia, 1202, Bulgaria
Novartis Investigative Site
Sofia, 1233, Bulgaria
Novartis Investigative Site
Sofia, 1309, Bulgaria
Novartis Investigative Site
Sofia, 1407, Bulgaria
Novartis Investigative Site
Sofia, 1527, Bulgaria
Novartis Investigative Site
Sofia, 1606, Bulgaria
Novartis Investigative Site
Sofia, 1784, Bulgaria
Novartis Investigative Site
Varna, 9010, Bulgaria
Novartis Investigative Site
Veliko Tarnovo, 5000, Bulgaria
Novartis Investigative Site
Calgary, Alberta, T2N 4Z6, Canada
Novartis Investigative Site
Victoria, British Columbia, V8R4R2, Canada
Novartis Investigative Site
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Novartis Investigative Site
Halifax, Nova Scotia, B3H 2Y9, Canada
Novartis Investigative Site
Cambridge, Ontario, N1R 6V6, Canada
Novartis Investigative Site
Hamilton, Ontario, L8L 2X2, Canada
Novartis Investigative Site
Ottawa, Ontario, K1Y 4W7, Canada
Novartis Investigative Site
Toronto, Ontario, M5B 1W8, Canada
Novartis Investigative Site
Toronto, Ontario, M5G 1X5, Canada
Novartis Investigative Site
Toronto, Ontario, M5S 1B2, Canada
Novartis Investigative Site
Weston, Ontario, M9N 1W4, Canada
Novartis Investigative Site
Montreal, Quebec, H1T 1C8, Canada
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Montreal, Quebec, H3G 1A4, Canada
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Montreal, Quebec, H3T 1E2, Canada
Novartis Investigative Site
Sainte-Foy, Quebec, G1V 4G5, Canada
Novartis Investigative Site
Sherbrooke, Quebec, J1G 2E8, Canada
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Thetford-Mines, Quebec, G6G 2V4, Canada
Novartis Investigative Site
Trois-Rivières, Quebec, G8Z 3R9, Canada
Novartis Investigative Site
Beijing, Beijing Municipality, 100037, China
Novartis Investigative Site
Beijing, Beijing Municipality, 100039, China
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Beijing, Beijing Municipality, 100044, China
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Beijing, Beijing Municipality, 100730, China
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Chongqing, Chongqing Municipality, 400010, China
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Lanzhou, Gansu, 730030, China
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Guangzhou, Guangdong, 51000, China
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Guangzhou, Guangdong, 510080, China
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Guangzhou, Guangdong, 510515, China
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Nanning, Guangxi, 530021, China
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Changsha, Hunan, 410003, China
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Nanjing, Jiangsu, 210009, China
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Nanjing, Jiangsu, 210029, China
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Suzhou, Jiangsu, 215004, China
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Wuxi, Jiangsu, China
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Nanchang, Jiangxi, 330006, China
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Changchun, Jilin, 130022, China
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Jilin, Jilin, 132000, China
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Shenyang, Liaoning, 110003, China
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Shenyang, Liaoning, 110016, China
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Shanghai, Shanghai Municipality, 200032, China
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Shanghai, Shanghai Municipality, 200120, China
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Shanghai, Shanghai Municipality, China
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Xian, Shanxi, 710061, China
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Xi’an, Shanxi, 710032, China
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Chengdu, Sichuan, 610041, China
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Tianjin, Tianjin Municipality, 300121, China
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Ürümqi, Xinjiang, 830054, China
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Hangzhou, Zhejiang, 310009, China
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Hangzhou, Zhejiang, 310013, China
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Hangzhou, Zhejiang, 310016, China
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Beijing, 100029, China
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Beijing, 100034, China
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Chongqing, 400037, China
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Jinan, 250012, China
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Nanjing, 210036, China
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Shanghai, 200025, China
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Shanghai, 200031, China
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Shanghai, 200080, China
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Medellín, Antioquia, 050036, Colombia
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Barranquilla, Atlántico, Colombia
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Barranquilla, 080020, Colombia
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Barranquilla, Colombia
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Florida Blanca, Colombia
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Varaždin, HRV, 42000, Croatia
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Rijeka, 51000, Croatia
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Zadar, 23000, Croatia
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Zagreb, 10000, Croatia
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Brandýs nad Labem, Czech Republic, 250 01, Czechia
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Brno, Czech Republic, 60200, Czechia
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Ivančice, Czech Republic, 66491, Czechia
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Kladno, Czech Republic, 272 80, Czechia
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Liberec, Czech Republic, 460 05, Czechia
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Louny, Czech Republic, Czechia
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Ostrava, Czech Republic, 70200, Czechia
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Pilsen, Czech Republic, 30100, Czechia
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Prague, Czech Republic, 140 21, Czechia
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Rožnov pod Radhoštěm, Czech Republic, 756 61, Czechia
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Svitavy, Czech Republic, 568 25, Czechia
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Třebíč, Czech Republic, 674 01, Czechia
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Ústí nad Labem, Czech Republic, 400 01, Czechia
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Znojmo, Czech Republic, 66902, Czechia
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Policska, CZE, 57201, Czechia
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Prague, CZE, 128 08, Czechia
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Ústí nad Labem, CZE, 400 01, Czechia
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CZE, 11000, Czechia
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Kolín, 280 20, Czechia
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Mariánské Lázně, 353 01, Czechia
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Uherské Hradiště, 68601, Czechia
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Esbjerg, DK-6700, Denmark
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Glostrup Municipality, 2600, Denmark
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Herlev, 2730, Denmark
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Hvidovre, 2650, Denmark
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Randers, 8930, Denmark
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Svendborg, 5700, Denmark
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Viborg, DK-8800, Denmark
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Jyväskylä, 40620, Finland
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Oulu, 90220, Finland
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Tampere, 33520, Finland
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Bayonne, Bayonne Cedex, 64109, France
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Montpellier, Herault, 34059, France
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Besançon, 25030, France
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Béziers, 34525, France
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Bordeaux, 33075, France
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Grenoble, 38043, France
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Lyon, F-69001, France
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Paris, 75010, France
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Poitiers, 86000, France
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Pontoise, F-95300, France
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Rennes, 35033, France
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Toulouse, 31059, France
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Tourcoing, 59208, France
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Vandœuvre-lès-Nancy, 54511, France
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Dresden, Saxony, 01099, Germany
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Aachen, 52074, Germany
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Bad Homburg, 61348, Germany
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Bad Krozingen, 79189, Germany
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Bamberg, 96049, Germany
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Berlin, 10789, Germany
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Berlin, 12157, Germany
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Berlin, 12683, Germany
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Berlin, 13086, Germany
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Berlin, 13353, Germany
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Berlin, 13405, Germany
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Buch, 13125, Germany
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Chemnitz, 09126, Germany
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Chemnitz, 09130, Germany
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Cologne, 51065, Germany
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Dessau, 06846, Germany
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Dresden, 01277, Germany
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Dresden, 01307, Germany
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Dresden, 01309, Germany
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Duisburg, 47137, Germany
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Eilenburg, D 04838, Germany
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Elsterwerda, 04910, Germany
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Essen, 45355, Germany
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Related Publications (55)
Yang M, Henderson AD, Anand IS, Desai AS, Lam CSP, Maggioni AP, Martinez FA, Rouleau JL, Swedberg K, Vaduganathan M, van Veldhuisen DJ, Zannad F, Zile MR, Packer M, Rizkala A, Lewis EF, Jhund PS, Solomon SD, McMurray JJV. Sacubitril/valsartan and quality of life assessed using the EuroQol Five-dimension Three-level questionnaire level sum score (EQ-5D-3L-LSS) in patients with HFrEF and HFmrEF/HFpEF. Eur Heart J Cardiovasc Pharmacother. 2025 Nov 4;11(7):574-589. doi: 10.1093/ehjcvp/pvaf064.
PMID: 40839760DERIVEDLu H, Claggett BL, Minamisawa M, Ostrominski JW, Foa A, Pabon MA, Kalayci A, Vaduganathan M, Cikes M, Shah AM, Desai AS, McMurray JJV, Jhund PS, Packer M, Lefkowitz M, Rouleau JL, Zile MR, Zannad F, Hegde SM, Solomon SD, Skali H. Prognostic Significance of Nutritional Scores in Patients With Heart Failure: Insights From the PARAGON-HF Trial. J Am Heart Assoc. 2025 May 6;14(9):e038872. doi: 10.1161/JAHA.124.038872. Epub 2025 Apr 23.
PMID: 40265602DERIVEDKondo T, Jhund PS, Anand IS, Claggett BL, Desai AS, Docherty KF, Lam CSP, Lefkowitz MP, Maggioni AP, Martinez FA, Redfield MM, Rouleau JL, Van Veldhuisen DJ, Zannad F, Zile MR, Packer M, Solomon SD, McMurray JJV. Effects of Sacubitril/Valsartan According to Natriuretic Peptide Levels in Patients Enrolled in PARADIGM-HF and PARAGON-HF. JACC Heart Fail. 2025 Jun;13(6):927-939. doi: 10.1016/j.jchf.2024.12.010. Epub 2025 Mar 12.
PMID: 40088233DERIVEDPeikert A, Vaduganathan M, Claggett BL, Kulac IJ, Litwin S, Zile M, Desai AS, Jhund PS, Butt JH, Lam CSP, Martinez F, Van Veldhuisen DJ, Zannad F, Rouleau J, Lefkowitz M, McMurray JJV, Solomon SD, Packer M. Near-universal prevalence of central adiposity in heart failure with preserved ejection fraction: the PARAGON-HF trial. Eur Heart J. 2025 Jul 1;46(25):2372-2390. doi: 10.1093/eurheartj/ehaf057.
PMID: 39873282DERIVEDMc Causland FR, Vaduganathan M, Claggett B, Gori M, Jhund PS, McGrath MM, Neuen BL, Packer M, Pfeffer MA, Rouleau JL, Senni M, Swedberg K, Zannad F, Zile M, Lefkowitz MP, McMurray JJV, Solomon SD. Angiotensin Receptor Neprilysin Inhibition and Cardiovascular Outcomes Across the Kidney Function Spectrum: The PARAGON-HF Trial. JACC Heart Fail. 2025 Jan;13(1):105-114. doi: 10.1016/j.jchf.2024.08.022. Epub 2024 Nov 20.
PMID: 39570234DERIVEDLu H, Claggett BL, Packer M, Pfeffer MA, Swedberg K, Rouleau J, Zile MR, Lefkowitz M, Desai AS, Jhund PS, McMurray JJV, Solomon SD, Vaduganathan M. Visit-to-visit changes in heart rate in heart failure: A pooled participant-level analysis of the PARADIGM-HF and PARAGON-HF trials. Eur J Heart Fail. 2025 Jan;27(1):60-68. doi: 10.1002/ejhf.3487. Epub 2024 Oct 22.
PMID: 39439294DERIVEDLu H, Claggett BL, Packer M, Pabon MA, Pfeffer MA, Lewis EF, Lam CSP, Rouleau J, Zile MR, Lefkowitz M, Desai AS, Jhund PS, McMurray JJV, Solomon SD, Vaduganathan M. Race in Heart Failure: A Pooled Participant-Level Analysis of the Global PARADIGM-HF and PARAGON-HF Trials. JACC Heart Fail. 2025 Jan;13(1):58-71. doi: 10.1016/j.jchf.2024.08.008. Epub 2024 Aug 31.
PMID: 39387766DERIVEDLu H, Claggett BL, Packer M, Pfeffer MA, Lam CSP, Zile MR, Desai AS, Jhund P, Lefkowitz M, McMurray JJV, Solomon SD, Vaduganathan M. Sacubitril/valsartan reduces incident anaemia and iron therapy utilization in heart failure: The PARAGON-HF trial. Eur J Heart Fail. 2025 Jan;27(1):85-95. doi: 10.1002/ejhf.3414. Epub 2024 Sep 1.
PMID: 39217577DERIVEDLu H, Chatur S, Lee S, Inciardi RM, Abanda M, Mc Causland FR, Kalayci A, Taheri KK, Shah AM, Cikes M, Claggett BL, Prasad N, Lam CSP, O'Meara E, Wang X, McMurray JJV, Pfeffer MA, Hegde SM, Solomon SD, Skali H. Relationship Between Cardiac Structure and Function With Renal Function Trajectory and Outcomes in Patients With Heart Failure: Insights From the PARAGON-HF Trial. Circ Heart Fail. 2024 Oct;17(10):e011942. doi: 10.1161/CIRCHEARTFAILURE.124.011942. Epub 2024 Aug 30.
PMID: 39212045DERIVEDLu H, Claggett BL, Packer M, Lam CSP, Swedberg K, Rouleau J, Zile MR, Lefkowitz M, Desai AS, Jhund P, McMurray JJV, Solomon SD, Vaduganathan M. Effects of Sacubitril/Valsartan on All-Cause Hospitalizations in Heart Failure: Post Hoc Analysis of the PARADIGM-HF and PARAGON-HF Randomized Clinical Trials. JAMA Cardiol. 2024 Nov 1;9(11):1047-1052. doi: 10.1001/jamacardio.2024.2566.
PMID: 39210725DERIVEDYoon M, Kim W, Kook W, Park JJ, Greenberg B. Analysis of the PARAGON-HF Study Results Using Win Ratio. Circ Heart Fail. 2024 Sep;17(9):e011860. doi: 10.1161/CIRCHEARTFAILURE.124.011860. Epub 2024 Aug 28.
PMID: 39193709DERIVEDLassen MCH, Ostrominski JW, Claggett BL, Packer M, Zile M, Desai AS, Shah AM, Cikes M, Merkely B, Gori M, Wang X, Hegde SM, Pfeffer MA, Lefkowitz M, McMurray JJV, Solomon SD, Vaduganathan M. Cardiovascular-kidney-metabolic overlap in heart failure with preserved ejection fraction: Cardiac structure and function, clinical outcomes, and response to sacubitril/valsartan in PARAGON-HF. Eur J Heart Fail. 2024 Aug;26(8):1762-1774. doi: 10.1002/ejhf.3304. Epub 2024 Jun 26.
PMID: 38932589DERIVEDPatel-Murray NL, Zhang L, Claggett BL, Xu D, Serrano-Fernandez P, Healey M, Wandel S, Chen CW, Jacob J, Xu H, Turner GM, Chutkow W, Yates DP, O'Donnell CJ, Prescott MF, Lefkowitz M, Gimpelewicz CR, Beste MT, Zhao F, Gou L, Desai AS, Jhund PS, Packer M, Pfeffer MA, Redfield MM, Rouleau JL, Zannad F, Zile MR, McMurray JJV, Mendelson MM, Solomon SD, Cunningham JW. Aptamer Proteomics for Biomarker Discovery in Heart Failure With Preserved Ejection Fraction: The PARAGON-HF Proteomic Substudy. J Am Heart Assoc. 2024 Jul 2;13(13):e033544. doi: 10.1161/JAHA.123.033544. Epub 2024 Jun 21.
PMID: 38904251DERIVEDChatur S, Beldhuis IE, Claggett BL, McCausland FR, Neuen BL, Desai AS, Rouleau JL, Zile MR, Packer M, Pfeffer MA, Lefkowitz MP, McMurray JJV, Solomon SD, Vaduganathan M. Sacubitril/Valsartan in Patients With Heart Failure and Deterioration in eGFR to <30 mL/min/1.73 m2. JACC Heart Fail. 2024 Oct;12(10):1692-1703. doi: 10.1016/j.jchf.2024.03.014. Epub 2024 Jun 5.
PMID: 38842957DERIVEDDewan P, Shen L, Pedro Ferreira J, Jhund PS, Anand IS, Chandra A, Chiang LM, Claggett B, Desai AS, Gong J, Lam CSP, Lefkowitz MP, Maggioni AP, Martinez F, Packer M, Redfield MM, Rouleau JL, van Veldhuisen DJ, Zannad F, Zile MR, Solomon SD, McMurray JJV. Effect of Sacubitril/Valsartan on Cognitive Function in Patients With Heart Failure With Preserved Ejection Fraction: A Prespecified Analysis of PARAGON-HF. Circulation. 2024 Jul 23;150(4):272-282. doi: 10.1161/CIRCULATIONAHA.124.068774. Epub 2024 Jun 6.
PMID: 38841854DERIVEDFoa A, Vaduganathan M, Claggett BL, Pabon MA, Lu H, Pfeffer MA, Packer M, Vardeny O, Rouleau JL, Lefkowitz M, Mentz RJ, Jhund PS, Desai AS, McMurray JJV, Solomon SD. Sacubitril/Valsartan-Related Hypotension in Patients With Heart Failure and Preserved or Mildly Reduced Ejection Fraction. J Am Coll Cardiol. 2024 May 7;83(18):1731-1739. doi: 10.1016/j.jacc.2024.02.035. Epub 2024 Mar 25.
PMID: 38537919DERIVEDBhatt AS, Vaduganathan M, Claggett BL, Kulac IJ, Anand IS, Desai AS, Fang JC, Hernandez AF, Jhund PS, Kosiborod MN, Sabatine MS, Shah SJ, Vardeny O, McMurray JJV, Solomon SD, Gaziano TA. Cost Effectiveness of Dapagliflozin for Heart Failure Across the Spectrum of Ejection Fraction: An Economic Evaluation Based on Pooled, Individual Participant Data From the DELIVER and DAPA-HF Trials. J Am Heart Assoc. 2024 Mar 5;13(5):e032279. doi: 10.1161/JAHA.123.032279. Epub 2024 Feb 23.
PMID: 38390793DERIVEDButt JH, Jering K, DE Boer RA, Claggett BL, Desai AS, Hernandez AF, Inzucchi SE, Jhund PS, Kober L, Kosiborod MN, Lam CSP, Martinez FA, Ponikowski P, Sabatine MS, Shah SJ, Vaduganathan M, Langkilde AM, Bengtsson O, Petersson M, Sjostrand M, Wilderang U, Solomon SD, McMurray JJV. Heart Failure, Investigator-Reported Sleep Apnea and Dapagliflozin: A Patient-Level Pooled Meta-Analysis of DAPA-HF and DELIVER. J Card Fail. 2024 Mar;30(3):436-448. doi: 10.1016/j.cardfail.2023.08.027. Epub 2023 Dec 15.
PMID: 38104937DERIVEDKondo T, Dewan P, Anand IS, Desai AS, Packer M, Zile MR, Pfeffer MA, Solomon SD, Abraham WT, Shah SJ, Lam CSP, Jhund PS, McMurray JJV. Clinical Characteristics and Outcomes in Patients With Heart Failure: Are There Thresholds and Inflection Points in Left Ventricular Ejection Fraction and Thresholds Justifying a Clinical Classification? Circulation. 2023 Aug 29;148(9):732-749. doi: 10.1161/CIRCULATIONAHA.122.063642. Epub 2023 Jun 27.
PMID: 37366061DERIVEDKondo T, Jering KS, Jhund PS, Anand IS, Desai AS, Lam CSP, Maggioni AP, Martinez FA, Packer M, Petrie MC, Pfeffer MA, Redfield MM, Rouleau JL, van Veldhuisen DJ, Zannad F, Zile MR, Solomon SD, McMurray JJV. Predicting Stroke in Heart Failure and Preserved Ejection Fraction Without Atrial Fibrillation. Circ Heart Fail. 2023 Jul;16(7):e010377. doi: 10.1161/CIRCHEARTFAILURE.122.010377. Epub 2023 Jun 23.
PMID: 37350280DERIVEDInciardi RM, Abanda M, Shah AM, Cikes M, Claggett B, Skali H, Vaduganathan M, Prasad N, Litwin S, Merkely B, Kosztin A, Nagy KV, Shah SJ, Mullens W, Zile MR, Lam CSP, Pfeffer MA, McMurray JJV, Solomon SD; PARAGON-HF Investigators. Right Ventricular Function and Pulmonary Coupling in Patients With Heart Failure and Preserved Ejection Fraction. J Am Coll Cardiol. 2023 Aug 8;82(6):489-499. doi: 10.1016/j.jacc.2023.05.010. Epub 2023 May 22.
PMID: 37225045DERIVEDLyu T, Bornkamp B, Mueller-Velten G, Schmidli H. Bayesian inference for a principal stratum estimand on recurrent events truncated by death. Biometrics. 2023 Dec;79(4):3792-3802. doi: 10.1111/biom.13831. Epub 2023 Jan 30.
PMID: 36647690DERIVEDCurtain JP, Adamson C, Kondo T, Butt JH, Desai AS, Zannad F, Rouleau JL, Rohde LE, Kober L, Anand IS, van Veldhuisen DJ, Zile MR, Lefkowitz MP, Solomon SD, Packer M, Petrie MC, Jhund PS, McMurray JJV. Investigator-reported ventricular arrhythmias and mortality in heart failure with mildly reduced or preserved ejection fraction. Eur Heart J. 2023 Feb 21;44(8):668-677. doi: 10.1093/eurheartj/ehac801.
PMID: 36632831DERIVEDButt JH, Dewan P, Jhund PS, Anand IS, Atar D, Ge J, Desai AS, Echeverria LE, Kober L, Lam CSP, Maggioni AP, Martinez F, Packer M, Rouleau JL, Sim D, Van Veldhuisen DJ, Vrtovec B, Zannad F, Zile MR, Gong J, Lefkowitz MP, Rizkala AR, Solomon SD, McMurray JJV. Sacubitril/Valsartan and Frailty in Patients With Heart Failure and Preserved Ejection Fraction. J Am Coll Cardiol. 2022 Sep 20;80(12):1130-1143. doi: 10.1016/j.jacc.2022.06.037. Epub 2022 Aug 29.
PMID: 36050227DERIVEDChatur S, Vaduganathan M, Peikert A, Claggett BL, McCausland FR, Skali H, Pfeffer MA, Beldhuis IE, Kober L, Seferovic P, Lefkowitz M, McMurray JJV, Solomon SD. Longitudinal trajectories in renal function before and after heart failure hospitalization among patients with heart failure with preserved ejection fraction in the PARAGON-HF trial. Eur J Heart Fail. 2022 Oct;24(10):1906-1914. doi: 10.1002/ejhf.2638. Epub 2022 Aug 15.
PMID: 35895867DERIVEDWijkman MO, Claggett B, Vaduganathan M, Cunningham JW, Rorth R, Jackson A, Packer M, Zile M, Rouleau J, Swedberg K, Lefkowitz M, Shah SJ, Pfeffer MA, McMurray JJV, Solomon SD. Effects of sacubitril/valsartan on glycemia in patients with diabetes and heart failure: the PARAGON-HF and PARADIGM-HF trials. Cardiovasc Diabetol. 2022 Jun 18;21(1):110. doi: 10.1186/s12933-022-01545-1.
PMID: 35717169DERIVEDVaduganathan M, Claggett BL, Inciardi RM, Fonarow GC, McMurray JJV, Solomon SD. Estimating the Benefits of Combination Medical Therapy in Heart Failure With Mildly Reduced and Preserved Ejection Fraction. Circulation. 2022 Jun 7;145(23):1741-1743. doi: 10.1161/CIRCULATIONAHA.121.058929. Epub 2022 May 23. No abstract available.
PMID: 35603667DERIVEDVaduganathan M, Claggett BL, McMurray JJV, Solomon SD. Health Status Trajectories Before and After Hospitalization for Heart Failure. Circulation. 2022 Jun 21;145(25):1872-1874. doi: 10.1161/CIRCULATIONAHA.122.059282. Epub 2022 May 21. No abstract available.
PMID: 35603665DERIVEDCikes M, Planinc I, Claggett B, Cunningham J, Milicic D, Sweitzer N, Senni M, Gori M, Linssen G, Shah SJ, Packer M, Pfeffer M, Zile MR, Anand I, Chiang LM, Lam CSP, Redfield M, Desai AS, McMurray JJV, Solomon SD. Atrial Fibrillation in Heart Failure With Preserved Ejection Fraction: The PARAGON-HF Trial. JACC Heart Fail. 2022 May;10(5):336-346. doi: 10.1016/j.jchf.2022.01.018. Epub 2022 Apr 6.
PMID: 35483796DERIVEDJackson AM, Rorth R, Liu J, Kristensen SL, Anand IS, Claggett BL, Cleland JGF, Chopra VK, Desai AS, Ge J, Gong J, Lam CSP, Lefkowitz MP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rizkala AR, Rouleau JL, Seferovic PM, Tromp J, Van Veldhuisen DJ, Yilmaz MB, Zannad F, Zile MR, Kober L, Petrie MC, Jhund PS, Solomon SD, McMurray JJV; PARAGON-HF Committees and Investigators. Diabetes and pre-diabetes in patients with heart failure and preserved ejection fraction. Eur J Heart Fail. 2022 Mar;24(3):497-509. doi: 10.1002/ejhf.2403. Epub 2022 Jan 4.
PMID: 34918855DERIVEDDesai AS, Vaduganathan M, Cleland JG, Claggett BL, Barkoudah E, Finn P, McCausland FR, Yilmaz MB, Lefkowitz M, Shi V, Pfeffer MA, McMurray JJV, Solomon SD. Mode of Death in Patients With Heart Failure and Preserved Ejection Fraction: Insights From PARAGON-HF Trial. Circ Heart Fail. 2021 Dec;14(12):e008597. doi: 10.1161/CIRCHEARTFAILURE.121.008597. Epub 2021 Nov 22.
PMID: 34807713DERIVEDMooney L, Hawkins NM, Jhund PS, Redfield MM, Vaduganathan M, Desai AS, Rouleau JL, Minamisawa M, Shah AM, Lefkowitz MP, Zile MR, Van Veldhuisen DJ, Pfeffer MA, Anand IS, Maggioni AP, Senni M, Claggett BL, Solomon SD, McMurray JJV. Impact of Chronic Obstructive Pulmonary Disease in Patients With Heart Failure With Preserved Ejection Fraction: Insights From PARAGON-HF. J Am Heart Assoc. 2021 Dec 7;10(23):e021494. doi: 10.1161/JAHA.121.021494. Epub 2021 Nov 19.
PMID: 34796742DERIVEDJackson AM, Jhund PS, Anand IS, Dungen HD, Lam CSP, Lefkowitz MP, Linssen G, Lund LH, Maggioni AP, Pfeffer MA, Rouleau JL, Saraiva JFK, Senni M, Vardeny O, Wijkman MO, Yilmaz MB, Saito Y, Zile MR, Solomon SD, McMurray JJV. Sacubitril-valsartan as a treatment for apparent resistant hypertension in patients with heart failure and preserved ejection fraction. Eur Heart J. 2021 Sep 21;42(36):3741-3752. doi: 10.1093/eurheartj/ehab499.
PMID: 34392331DERIVEDFelker GM, Butler J, Januzzi JL Jr, Desai AS, McMurray JJV, Solomon SD. Probabilistic Readjudication of Heart Failure Hospitalization Events in the PARAGON-HF Study. Circulation. 2021 Jun 8;143(23):2316-2318. doi: 10.1161/CIRCULATIONAHA.121.054496. Epub 2021 Jun 7. No abstract available.
PMID: 34097449DERIVEDSelvaraj S, Claggett BL, Packer M, Zannad F, Anand IS, Pieske B, Zhao Z, Shi VC, Lefkowitz MP, McMurray JJV, Solomon SD. Effects of Sacubitril/Valsartan on Serum Lipids in Heart Failure With Preserved Ejection Fraction. J Am Heart Assoc. 2021 Sep 7;10(17):e022069. doi: 10.1161/JAHA.121.022069. Epub 2021 May 16.
PMID: 33998278DERIVEDShen L, Jhund PS, Anand IS, Bhatt AS, Desai AS, Maggioni AP, Martinez FA, Pfeffer MA, Rizkala AR, Rouleau JL, Swedberg K, Vaduganathan M, Vardeny O, van Veldhuisen DJ, Zannad F, Zile MR, Packer M, Solomon SD, McMurray JJV. Incidence and Outcomes of Pneumonia in Patients With Heart Failure. J Am Coll Cardiol. 2021 Apr 27;77(16):1961-1973. doi: 10.1016/j.jacc.2021.03.001.
PMID: 33888245DERIVEDTromp J, Claggett BL, Liu J, Jackson AM, Jhund PS, Kober L, Widimsky J, Boytsov SA, Chopra VK, Anand IS, Ge J, Chen CH, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rouleau JL, Van Veldhuisen DJ, Zannad F, Zile MR, Rizkala AR, Inubushi-Molessa A, Lefkowitz MP, Shi VC, McMurray JJV, Solomon SD, Lam CSP; PARAGON-HF Investigators. Global Differences in Heart Failure With Preserved Ejection Fraction: The PARAGON-HF Trial. Circ Heart Fail. 2021 Apr;14(4):e007901. doi: 10.1161/CIRCHEARTFAILURE.120.007901. Epub 2021 Apr 19.
PMID: 33866828DERIVEDVaduganathan M, Cunningham JW, Claggett BL, Causland FM, Barkoudah E, Finn P, Zannad F, Pfeffer MA, Rizkala AR, Sabarwal S, McMurray JJV, Solomon S, Desai AS. Worsening Heart Failure Episodes Outside a Hospital Setting in Heart Failure With Preserved Ejection Fraction: The PARAGON-HF Trial. JACC Heart Fail. 2021 May;9(5):374-382. doi: 10.1016/j.jchf.2021.01.014. Epub 2021 Apr 7.
PMID: 33839075DERIVEDGronda E, Vanoli E, Iacoviello M. The PARAGON-HF trial: the sacubitril/valsartan in heart failure with preserved ejection fraction. Eur Heart J Suppl. 2020 Nov 18;22(Suppl L):L77-L81. doi: 10.1093/eurheartj/suaa140. eCollection 2020 Nov.
PMID: 33727901DERIVEDJering K, Claggett B, Redfield MM, Shah SJ, Anand IS, Martinez F, Sabarwal SV, Seferovic PM, Kerr Saraiva JF, Katova T, Lefkowitz MP, Pfeffer MA, McMurray JJV, Solomon SD. Burden of Heart Failure Signs and Symptoms, Prognosis, and Response to Therapy: The PARAGON-HF Trial. JACC Heart Fail. 2021 May;9(5):386-397. doi: 10.1016/j.jchf.2021.01.011. Epub 2021 Mar 10.
PMID: 33714741DERIVEDJering KS, Zannad F, Claggett B, Mc Causland FR, Ferreira JP, Desai A, Barkoudah E, McMurray JJV, Pfeffer MA, Solomon SD. Cardiovascular and Renal Outcomes of Mineralocorticoid Receptor Antagonist Use in PARAGON-HF. JACC Heart Fail. 2021 Jan;9(1):13-24. doi: 10.1016/j.jchf.2020.08.014. Epub 2020 Nov 11.
PMID: 33189633DERIVEDMc Causland FR, Lefkowitz MP, Claggett B, Anavekar NS, Senni M, Gori M, Jhund PS, McGrath MM, Packer M, Shi V, Van Veldhuisen DJ, Zannad F, Comin-Colet J, Pfeffer MA, McMurray JJV, Solomon SD. Angiotensin-Neprilysin Inhibition and Renal Outcomes in Heart Failure With Preserved Ejection Fraction. Circulation. 2020 Sep 29;142(13):1236-1245. doi: 10.1161/CIRCULATIONAHA.120.047643. Epub 2020 Aug 17.
PMID: 32845715DERIVEDCunningham JW, Claggett BL, O'Meara E, Prescott MF, Pfeffer MA, Shah SJ, Redfield MM, Zannad F, Chiang LM, Rizkala AR, Shi VC, Lefkowitz MP, Rouleau J, McMurray JJV, Solomon SD, Zile MR. Effect of Sacubitril/Valsartan on Biomarkers of Extracellular Matrix Regulation in Patients With HFpEF. J Am Coll Cardiol. 2020 Aug 4;76(5):503-514. doi: 10.1016/j.jacc.2020.05.072.
PMID: 32731928DERIVEDCunningham JW, Vaduganathan M, Claggett BL, Zile MR, Anand IS, Packer M, Zannad F, Lam CSP, Janssens S, Jhund PS, Kober L, Rouleau J, Shah SJ, Chopra VK, Shi VC, Lefkowitz MP, Prescott MF, Pfeffer MA, McMurray JJV, Solomon SD. Effects of Sacubitril/Valsartan on N-Terminal Pro-B-Type Natriuretic Peptide in Heart Failure With Preserved Ejection Fraction. JACC Heart Fail. 2020 May;8(5):372-381. doi: 10.1016/j.jchf.2020.03.002. Epub 2020 Mar 30.
PMID: 32241619DERIVEDSelvaraj S, Claggett BL, Bohm M, Anker SD, Vaduganathan M, Zannad F, Pieske B, Lam CSP, Anand IS, Shi VC, Lefkowitz MP, McMurray JJV, Solomon SD. Systolic Blood Pressure in Heart Failure With Preserved Ejection Fraction Treated With Sacubitril/Valsartan. J Am Coll Cardiol. 2020 Apr 14;75(14):1644-1656. doi: 10.1016/j.jacc.2020.02.009. Epub 2020 Mar 16.
PMID: 32192799DERIVEDShah AM, Cikes M, Prasad N, Li G, Getchevski S, Claggett B, Rizkala A, Lukashevich I, O'Meara E, Ryan JJ, Shah SJ, Mullens W, Zile MR, Lam CSP, McMurray JJV, Solomon SD; PARAGON-HF Investigators. Echocardiographic Features of Patients With Heart Failure and Preserved Left Ventricular Ejection Fraction. J Am Coll Cardiol. 2019 Dec 10;74(23):2858-2873. doi: 10.1016/j.jacc.2019.09.063.
PMID: 31806129DERIVEDSolomon SD, Vaduganathan M, L Claggett B, Packer M, Zile M, Swedberg K, Rouleau J, A Pfeffer M, Desai A, Lund LH, Kober L, Anand I, Sweitzer N, Linssen G, Merkely B, Luis Arango J, Vinereanu D, Chen CH, Senni M, Sibulo A, Boytsov S, Shi V, Rizkala A, Lefkowitz M, McMurray JJV. Sacubitril/Valsartan Across the Spectrum of Ejection Fraction in Heart Failure. Circulation. 2020 Feb 4;141(5):352-361. doi: 10.1161/CIRCULATIONAHA.119.044586. Epub 2019 Nov 17.
PMID: 31736342DERIVEDMcMurray JJV, Jackson AM, Lam CSP, Redfield MM, Anand IS, Ge J, Lefkowitz MP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Rizkala AR, Sabarwal SV, Shah AM, Shah SJ, Shi VC, van Veldhuisen DJ, Zannad F, Zile MR, Cikes M, Goncalvesova E, Katova T, Kosztin A, Lelonek M, Sweitzer N, Vardeny O, Claggett B, Jhund PS, Solomon SD. Effects of Sacubitril-Valsartan Versus Valsartan in Women Compared With Men With Heart Failure and Preserved Ejection Fraction: Insights From PARAGON-HF. Circulation. 2020 Feb 4;141(5):338-351. doi: 10.1161/CIRCULATIONAHA.119.044491. Epub 2019 Nov 17.
PMID: 31736337DERIVEDVaduganathan M, Claggett BL, Desai AS, Anker SD, Perrone SV, Janssens S, Milicic D, Arango JL, Packer M, Shi VC, Lefkowitz MP, McMurray JJV, Solomon SD. Prior Heart Failure Hospitalization, Clinical Outcomes, and Response to Sacubitril/Valsartan Compared With Valsartan in HFpEF. J Am Coll Cardiol. 2020 Jan 28;75(3):245-254. doi: 10.1016/j.jacc.2019.11.003. Epub 2019 Nov 11.
PMID: 31726194DERIVEDSolomon SD, McMurray JJV, Anand IS, Ge J, Lam CSP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rouleau JL, van Veldhuisen DJ, Zannad F, Zile MR, Desai AS, Claggett B, Jhund PS, Boytsov SA, Comin-Colet J, Cleland J, Dungen HD, Goncalvesova E, Katova T, Kerr Saraiva JF, Lelonek M, Merkely B, Senni M, Shah SJ, Zhou J, Rizkala AR, Gong J, Shi VC, Lefkowitz MP; PARAGON-HF Investigators and Committees. Angiotensin-Neprilysin Inhibition in Heart Failure with Preserved Ejection Fraction. N Engl J Med. 2019 Oct 24;381(17):1609-1620. doi: 10.1056/NEJMoa1908655. Epub 2019 Sep 1.
PMID: 31475794DERIVEDChandra A, Vaduganathan M, Lewis EF, Claggett BL, Rizkala AR, Wang W, Lefkowitz MP, Shi VC, Anand IS, Ge J, Lam CSP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rouleau JL, Van Veldhuisen DJ, Zannad F, Zile MR, McMurray JJV, Solomon SD; PARAGON-HF Investigators. Health-Related Quality of Life in Heart Failure With Preserved Ejection Fraction: The PARAGON-HF Trial. JACC Heart Fail. 2019 Oct;7(10):862-874. doi: 10.1016/j.jchf.2019.05.015. Epub 2019 Jul 10.
PMID: 31302043DERIVEDSolomon SD, Rizkala AR, Lefkowitz MP, Shi VC, Gong J, Anavekar N, Anker SD, Arango JL, Arenas JL, Atar D, Ben-Gal T, Boytsov SA, Chen CH, Chopra VK, Cleland J, Comin-Colet J, Duengen HD, Echeverria Correa LE, Filippatos G, Flammer AJ, Galinier M, Godoy A, Goncalvesova E, Janssens S, Katova T, Kober L, Lelonek M, Linssen G, Lund LH, O'Meara E, Merkely B, Milicic D, Oh BH, Perrone SV, Ranjith N, Saito Y, Saraiva JF, Shah S, Seferovic PM, Senni M, Sibulo AS Jr, Sim D, Sweitzer NK, Taurio J, Vinereanu D, Vrtovec B, Widimsky J Jr, Yilmaz MB, Zhou J, Zweiker R, Anand IS, Ge J, Lam CSP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rouleau JL, Van Veldhuisen DJ, Zannad F, Zile MR, McMurray JJV. Baseline Characteristics of Patients With Heart Failure and Preserved Ejection Fraction in the PARAGON-HF Trial. Circ Heart Fail. 2018 Jul;11(7):e004962. doi: 10.1161/CIRCHEARTFAILURE.118.004962.
PMID: 29980595DERIVEDMutze T, Glimm E, Schmidli H, Friede T. Group sequential designs with robust semiparametric recurrent event models. Stat Methods Med Res. 2019 Aug;28(8):2385-2403. doi: 10.1177/0962280218780538. Epub 2018 Jun 11.
PMID: 29890892DERIVEDSolomon SD, Rizkala AR, Gong J, Wang W, Anand IS, Ge J, Lam CSP, Maggioni AP, Martinez F, Packer M, Pfeffer MA, Pieske B, Redfield MM, Rouleau JL, Van Veldhuisen DJ, Zannad F, Zile MR, Desai AS, Shi VC, Lefkowitz MP, McMurray JJV. Angiotensin Receptor Neprilysin Inhibition in Heart Failure With Preserved Ejection Fraction: Rationale and Design of the PARAGON-HF Trial. JACC Heart Fail. 2017 Jul;5(7):471-482. doi: 10.1016/j.jchf.2017.04.013. Epub 2017 Jun 26.
PMID: 28662936DERIVEDRossi A, Gheorghiade M, Triposkiadis F, Solomon SD, Pieske B, Butler J. Left atrium in heart failure with preserved ejection fraction: structure, function, and significance. Circ Heart Fail. 2014 Nov;7(6):1042-9. doi: 10.1161/CIRCHEARTFAILURE.114.001276. No abstract available.
PMID: 25415957DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2013
First Posted
August 12, 2013
Study Start
July 18, 2014
Primary Completion
June 7, 2019
Study Completion
June 7, 2019
Last Updated
September 29, 2020
Results First Posted
September 29, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.