Irbesartan in Heart Failure With Preserved Systolic Function (I-Preserve)
1 other identifier
interventional
4,128
25 countries
229
Brief Summary
The purpose of this clinical research study is to learn if Irbesartan is superior to placebo in reducing mortality and cardiovascular morbidity in subjects with heart failure with preserved systolic function. The safety of this treatment will also be studied.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2002
Longer than P75 for phase_3
229 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
Study Start
First participant enrolled
June 1, 2002
CompletedFirst Submitted
Initial submission to the registry
November 1, 2004
CompletedFirst Posted
Study publicly available on registry
November 2, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedResults Posted
Study results publicly available
June 8, 2010
CompletedApril 7, 2015
March 1, 2015
6.1 years
November 1, 2004
December 16, 2009
March 18, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With First Occurrence of the Composite Outcome of Death (All Cause) or Protocol-Specified Cardiovascular (CV) Hospitalization at Given Timepoints
Treatment comparisons for time to first occurrence of composite outcome of all-cause death (composite outcome of death) or protocol-specified CV hospitalization. Protocol-specified CV hospitalizations include those ≥24 hrs or involving a calendar date change for a primary cause of worsening heart failure, unstable angina, myocardial infarction, ventricular or atrial dysrhythmia, or stroke, that also require intravenous or intramuscular therapy or a related procedure or significant augmentation of oral therapy. In addition, MI or stroke during any hospitalization are included.
Year 1, Year 2, Year 3, Year 4, Year 5
Secondary Outcomes (18)
Percentage of Participants Experiencing Heart Failure Mortality or Heart Failure Hospitalization at Given Time Points
Year 1, Year 2, Year 3, Year 4, Year 5
Minnesota Living With Heart Failure (MLwHF) Total Score (Sum of Questions 1-21) at Month 6 and Month 14
Baseline, Month 6, Month 14
Minnesota Living With Heart Failure (MLwHF) Total Score (Sum of Questions 1-21) at Final Visit
Baseline, Final Visit=last scheduled visit specified in the protocol at conclusion of the entire study by the sponsor. The trial was designed to end after 1440 primary endpoint events, projected duration=6.0 ± 0.5 years.
Change From Baseline in B-Type Natriuretic Peptide (Pro-BNP) at Month 6 and Month 14
Baseline, Month 6, Month 14
Percentage of Participants Experiencing CV Death, Non-Fatal Myocardial Infarction (MI), or Non-Fatal Stroke at Given Timepoints
Year 1, Year 2, Year 3, Year 4, Year 5
- +13 more secondary outcomes
Study Arms (2)
1
ACTIVE COMPARATOR2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Male or female age \>= 60 years with current symptoms of heart failure consistent with New York Heart Association (NYHA) class II-IV
- Left ventricular ejection fraction (LVEF) \> = 45%
- Willing to provide written informed consent AND hospitalization for heart failure within the past 6 months OR various abnormalities in electrocardiogram, echocardiogram or chest x-ray indicating heart disease.
You may not qualify if:
- Acute myocardial infarction within 3 months;
- Heart revascularization procedure within 3 months;
- Hospitalization for angina within 3 months;
- Other heart surgery
- Life-threatening or uncontrolled arrhythmia
- Subjects with an implantable cardioverter-defibrillator that has discharged in the past 3 months;
- Stroke or surgery of the arteries in the brain within 3 months;
- Serious lung disease which requires use of home oxygen.
- Significantly low blood pressure
- Significantly high blood pressure
- Other known diseases that may limit life expectancy to \<3 years;
- Known or suspected bilateral kidney artery narrowing;
- Geographic or social factors making study participation and follow-up impractical.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bristol-Myers Squibblead
- Sanoficollaborator
Study Sites (229)
Local Institution
Birmingham, Alabama, United States
Local Institution
Peoria, Arizona, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Los Angeles, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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Farmington, Connecticut, United States
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Jacksonville, Florida, United States
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Jacksonville Beach, Florida, United States
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Lake Worth, Florida, United States
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Tampa, Florida, United States
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Vero Beach, Florida, United States
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Chicago, Illinois, United States
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Peoria, Illinois, United States
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Jeffersonville, Indiana, United States
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Louisville, Kentucky, United States
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Chalmette, Louisiana, United States
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Shreveport, Louisiana, United States
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Auburn, Maine, United States
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Takoma Park, Maryland, United States
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Towson, Maryland, United States
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Boston, Massachusetts, United States
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Haverhill, Massachusetts, United States
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Natick, Massachusetts, United States
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Detroit, Michigan, United States
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Petoskey, Michigan, United States
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Minneapolis, Minnesota, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Reno, Nevada, United States
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Lebanon, New Hampshire, United States
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Elmer, New Jersey, United States
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Albuquerque, New Mexico, United States
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Albany, New York, United States
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East Syracuse, New York, United States
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Flushing, New York, United States
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Rochester, New York, United States
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The Bronx, New York, United States
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Troy, New York, United States
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Chapel Hill, North Carolina, United States
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Concord, North Carolina, United States
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Durham, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Canton, Ohio, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Lorain, Ohio, United States
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Sandusky, Ohio, United States
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Portland, Oregon, United States
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Flourtown, Pennsylvania, United States
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Lancaster, Pennsylvania, United States
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Charleston, South Carolina, United States
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Germantown, Tennessee, United States
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Austin, Texas, United States
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Lynchberg, Virginia, United States
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Richmond, Virginia, United States
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South Boston, Virginia, United States
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Spokane, Washington, United States
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Madison, Wisconsin, United States
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Buenos Aires, Buenos Aires, Argentina
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San Martín, Buenos Aires, Argentina
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Corrientes, Corrientes Province, Argentina
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Córdoba, Córdoba Province, Argentina
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Mendoza, Mendoza Province, Argentina
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Rosario, Santa Fe Province, Argentina
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Coffs Harbour, New South Wales, Australia
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Concord, New South Wales, Australia
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Garran, New South Wales, Australia
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Kogarah, New South Wales, Australia
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Randwick, New South Wales, Australia
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Auchenflower, Queensland, Australia
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Brisbane, Queensland, Australia
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Woolloongabba, Queensland, Australia
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Launceston, Tasmania, Australia
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Geelong, Victoria, Australia
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Prahran, Victoria, Australia
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Aalst, Belgium
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Aye, Belgium
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Borgerhout, Belgium
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Genk-waterschei, Belgium
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Ghent, Belgium
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Hasselt, Belgium
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Huy, Belgium
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Leuven, Belgium
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Verviers, Belgium
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Salvador, Estado de Bahia, Brazil
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Goiania-go, Goiás, Brazil
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Belo Horizonte, Minas Gerais, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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Campinas, São Paulo, Brazil
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Sao Paulo, Sp, São Paulo, Brazil
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Calgary, Alberta, Canada
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Victoria, British Columbia, Canada
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Ajax, Ontario, Canada
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Hamilton, Ontario, Canada
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Rexdale, Ontario, Canada
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Scarborough Village, Ontario, Canada
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Toronto, Ontario, Canada
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Weston, Ontario, Canada
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Longueuil, Quebec, Canada
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Montreal, Quebec, Canada
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Saint-Lambert, Quebec, Canada
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Ste-Foy, Quebec, Canada
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Prague, Czechia
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Ústí nad Labem, Czechia
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Copenhagen, Denmark
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Copenhagen Nv, Denmark
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Abbeville, France
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Cholet, France
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Dax, France
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Gap, France
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Langres, France
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Lille, France
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Montbéliard, France
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Paris, France
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Poissy, France
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Pontoise, France
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Provins, France
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Roubaix, France
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Rouen, France
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St-Malo, France
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Tours, France
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Vandœuvre-lès-Nancy, France
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Vichy, France
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Bad Homburg, Germany
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Berlin, Germany
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Göttingen, Germany
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Gunzenhausen, Germany
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Halle, Germany
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Homburg / Saar, Germany
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Jena, Germany
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Langen, Germany
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Leipzig, Germany
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Mainz, Germany
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Marburg, Germany
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München, Germany
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Regensburg, Germany
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Stuttgart, Germany
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Witten, Germany
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Würzburg, Germany
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Athens, Greece
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Pátrai, Greece
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Budapest, Hungary
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Debrecen, Hungary
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Siófok, Hungary
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Szeged, Hungary
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County Dublin, Dublin, Ireland
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Dublin, Dublin, Ireland
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Ascoli Piceno, Italy
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Bologna, Italy
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Brescia, Italy
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Cosenza, Italy
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Pavia, Italy
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Perugia, Italy
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Piacenza, Italy
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Roma, Italy
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Siena, Italy
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Trieste, Italy
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Udine, Italy
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Aguascalientes, Aguascalientes, Mexico
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Guadalajara, Jalisco, Mexico
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Mexico City, Mexico City, Mexico
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San Pedro Garza García, Nuevo León, Mexico
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Alkmaar, Netherlands
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Almere Stad, Netherlands
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Amersfoort, Netherlands
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Apeldoorn, Netherlands
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Assen, Netherlands
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Breda, Netherlands
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Delft, Netherlands
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Emmen, Netherlands
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Gorinchem, Netherlands
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Groningen, Netherlands
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Heemstede, Netherlands
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Helmond, Netherlands
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Hengelo Ov, Netherlands
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Nijmegen, Netherlands
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Rotterdam, Netherlands
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Sittard, Netherlands
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Sneek, Netherlands
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Veldhoven, Netherlands
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Vlaardingen, Netherlands
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Zaandam, Netherlands
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Baerum Postterminal, Norway
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Stavanger, Norway
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Tønsberg, Norway
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Bydgoszcz, Poland
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Katowice, Poland
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Piotrkow Tryb., Poland
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Stalowa Wola, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Lisbon, Portugal
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Matosinhos Municipality, Portugal
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Moscow, Russia
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Saint Petersburg, Russia
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Saratov, Russia
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Johannesburg, Gauteng, South Africa
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Morningside, Gauteng, South Africa
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Parktown West, Gauteng, South Africa
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Berea, KwaZulu-Natal, South Africa
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KwaKhangela, KwaZulu-Natal, South Africa
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A Coruña, Spain
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Barcelona, Spain
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Córdoba, Spain
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Madrid, Spain
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Málaga, Spain
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Murcia, Spain
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Palma de Mallorca, Spain
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Seville, Spain
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Valencia, Spain
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Zaragoza, Spain
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Falun, Sweden
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Gothenburg, Sweden
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Linköping, Sweden
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Malmo, Sweden
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Skellefteå, Sweden
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Stockholm, Sweden
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Sundsvall, Sweden
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Bellinzona, Switzerland
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Liestal, Switzerland
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Zurich, Switzerland
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Glasgow, Dumbartonshire, United Kingdom
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Romford, Essex, United Kingdom
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Londonderry, Londonderry, United Kingdom
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Hull, Yorkshire, United Kingdom
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York, Yorkshire, United Kingdom
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Dundee, United Kingdom
Related Publications (25)
Massie BM, Carson PE, McMurray JJ, Komajda M, McKelvie R, Zile MR, Anderson S, Donovan M, Iverson E, Staiger C, Ptaszynska A; I-PRESERVE Investigators. Irbesartan in patients with heart failure and preserved ejection fraction. N Engl J Med. 2008 Dec 4;359(23):2456-67. doi: 10.1056/NEJMoa0805450. Epub 2008 Nov 11.
PMID: 19001508RESULTZile MR, Gaasch WH, Anand IS, Haass M, Little WC, Miller AB, Lopez-Sendon J, Teerlink JR, White M, McMurray JJ, Komajda M, McKelvie R, Ptaszynska A, Hetzel SJ, Massie BM, Carson PE; I-Preserve Investigators. Mode of death in patients with heart failure and a preserved ejection fraction: results from the Irbesartan in Heart Failure With Preserved Ejection Fraction Study (I-Preserve) trial. Circulation. 2010 Mar 30;121(12):1393-405. doi: 10.1161/CIRCULATIONAHA.109.909614. Epub 2010 Mar 15.
PMID: 20231531RESULTMcMurray JJ, Carson PE, Komajda M, McKelvie R, Zile MR, Ptaszynska A, Staiger C, Donovan JM, Massie BM. Heart failure with preserved ejection fraction: clinical characteristics of 4133 patients enrolled in the I-PRESERVE trial. Eur J Heart Fail. 2008 Feb;10(2):149-56. doi: 10.1016/j.ejheart.2007.12.010.
PMID: 18279770RESULTCarson P, Massie BM, McKelvie R, McMurray J, Komajda M, Zile M, Ptaszynska A, Frangin G; I-PRESERVE Investigators. The irbesartan in heart failure with preserved systolic function (I-PRESERVE) trial: rationale and design. J Card Fail. 2005 Oct;11(8):576-85. doi: 10.1016/j.cardfail.2005.06.432.
PMID: 16230259RESULTMcKelvie RS, Komajda M, McMurray J, Zile M, Ptaszynska A, Donovan M, Carson P, Massie BM; I-Preserve Investigators. Baseline plasma NT-proBNP and clinical characteristics: results from the irbesartan in heart failure with preserved ejection fraction trial. J Card Fail. 2010 Feb;16(2):128-34. doi: 10.1016/j.cardfail.2009.09.007. Epub 2009 Nov 4.
PMID: 20142024RESULTLassen MCH, Ostrominski JW, Claggett BL, Neuen BL, Beldhuis IE, Butt JH, Biering-Sorensen T, Desai AS, Lewis EF, Jhund PS, Mc Causland F, Anand IS, Pfeffer MA, Pitt B, Zannad F, Zile MR, McMurray JJV, Solomon SD, Vaduganathan M. Obesity and Risk of Kidney Outcomes in Heart Failure With Preserved Ejection Fraction: A Participant-Level Pooled Analysis of 4 Contemporary Trials. JACC Heart Fail. 2025 Aug;13(8):102498. doi: 10.1016/j.jchf.2025.03.042. Epub 2025 Jun 9.
PMID: 40494011DERIVEDKondo T, Campbell R, Jhund PS, Anand IS, Carson PE, Lam CSP, Shah SJ, Vaduganathan M, Zannad F, Zile MR, Solomon SD, McMurray JJV. Low Natriuretic Peptide Levels and Outcomes in Patients With Heart Failure and Preserved Ejection Fraction. JACC Heart Fail. 2024 Aug;12(8):1442-1455. doi: 10.1016/j.jchf.2024.04.027. Epub 2024 Jun 19.
PMID: 38904646DERIVEDKondo 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: 37350280DERIVEDCurtain 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: 36632831DERIVEDShen L, Jhund PS, Anand IS, Carson PE, Desai AS, Granger CB, Kober L, Komajda M, McKelvie RS, Pfeffer MA, Solomon SD, Swedberg K, Zile MR, McMurray JJV. Developing and validating models to predict sudden death and pump failure death in patients with heart failure and preserved ejection fraction. Clin Res Cardiol. 2021 Aug;110(8):1234-1248. doi: 10.1007/s00392-020-01786-8. Epub 2020 Dec 10.
PMID: 33301080DERIVEDTromp J, Shen L, Jhund PS, Anand IS, Carson PE, Desai AS, Granger CB, Komajda M, McKelvie RS, Pfeffer MA, Solomon SD, Kober L, Swedberg K, Zile MR, Pitt B, Lam CSP, McMurray JJV. Age-Related Characteristics and Outcomes of Patients With Heart Failure With Preserved Ejection Fraction. J Am Coll Cardiol. 2019 Aug 6;74(5):601-612. doi: 10.1016/j.jacc.2019.05.052.
PMID: 31370950DERIVEDKristensen SL, Mogensen UM, Jhund PS, Rorth R, Anand IS, Carson PE, Desai AS, Pitt B, Pfeffer MA, Solomon SD, Zile MR, Kober L, McMurray JJV. N-Terminal Pro-B-Type Natriuretic Peptide Levels for Risk Prediction in Patients With Heart Failure and Preserved Ejection Fraction According to Atrial Fibrillation Status. Circ Heart Fail. 2019 Mar;12(3):e005766. doi: 10.1161/CIRCHEARTFAILURE.118.005766.
PMID: 30871349DERIVEDKristensen SL, Mogensen UM, Jhund PS, Petrie MC, Preiss D, Win S, Kober L, McKelvie RS, Zile MR, Anand IS, Komajda M, Gottdiener JS, Carson PE, McMurray JJ. Clinical and Echocardiographic Characteristics and Cardiovascular Outcomes According to Diabetes Status in Patients With Heart Failure and Preserved Ejection Fraction: A Report From the I-Preserve Trial (Irbesartan in Heart Failure With Preserved Ejection Fraction). Circulation. 2017 Feb 21;135(8):724-735. doi: 10.1161/CIRCULATIONAHA.116.024593. Epub 2017 Jan 4.
PMID: 28052977DERIVEDGandhi PU, Chow SL, Rector TS, Krum H, Gaggin HK, McMurray JJ, Zile MR, Komajda M, McKelvie RS, Carson PE, Januzzi JL Jr, Anand IS. Prognostic Value of Insulin-Like Growth Factor-Binding Protein 7 in Patients with Heart Failure and Preserved Ejection Fraction. J Card Fail. 2017 Jan;23(1):20-28. doi: 10.1016/j.cardfail.2016.06.006. Epub 2016 Jun 16.
PMID: 27317843DERIVEDBadar AA, Perez-Moreno AC, Hawkins NM, Jhund PS, Brunton AP, Anand IS, McKelvie RS, Komajda M, Zile MR, Carson PE, Gardner RS, Petrie MC, McMurray JJ. Clinical Characteristics and Outcomes of Patients With Coronary Artery Disease and Angina: Analysis of the Irbesartan in Patients With Heart Failure and Preserved Systolic Function Trial. Circ Heart Fail. 2015 Jul;8(4):717-24. doi: 10.1161/CIRCHEARTFAILURE.114.002024. Epub 2015 Jun 11.
PMID: 26067854DERIVEDOluleye OW, Rector TS, Win S, McMurray JJ, Zile MR, Komajda M, McKelvie RS, Massie B, Carson PE, Anand IS. History of atrial fibrillation as a risk factor in patients with heart failure and preserved ejection fraction. Circ Heart Fail. 2014 Nov;7(6):960-6. doi: 10.1161/CIRCHEARTFAILURE.114.001523. Epub 2014 Sep 15.
PMID: 25225241DERIVEDBohm M, Perez AC, Jhund PS, Reil JC, Komajda M, Zile MR, McKelvie RS, Anand IS, Massie BM, Carson PE, McMurray JJ; I-Preserve Committees and Investigators. Relationship between heart rate and mortality and morbidity in the irbesartan patients with heart failure and preserved systolic function trial (I-Preserve). Eur J Heart Fail. 2014 Jul;16(7):778-87. doi: 10.1002/ejhf.85. Epub 2014 May 23.
PMID: 24864045DERIVEDLam CS, Carson PE, Anand IS, Rector TS, Kuskowski M, Komajda M, McKelvie RS, McMurray JJ, Zile MR, Massie BM, Kitzman DW. Sex differences in clinical characteristics and outcomes in elderly patients with heart failure and preserved ejection fraction: the Irbesartan in Heart Failure with Preserved Ejection Fraction (I-PRESERVE) trial. Circ Heart Fail. 2012 Sep 1;5(5):571-8. doi: 10.1161/CIRCHEARTFAILURE.112.970061. Epub 2012 Aug 10.
PMID: 22887722DERIVEDRector TS, Carson PE, Anand IS, McMurray JJ, Zile MR, McKelvie RS, Komajda M, Kuskowski M, Massie BM; I-PRESERVE Trial Investigators. Assessment of long-term effects of irbesartan on heart failure with preserved ejection fraction as measured by the minnesota living with heart failure questionnaire in the irbesartan in heart failure with preserved systolic function (I-PRESERVE) trial. Circ Heart Fail. 2012 Mar 1;5(2):217-25. doi: 10.1161/CIRCHEARTFAILURE.111.964221. Epub 2012 Jan 20.
PMID: 22267751DERIVEDZile MR, Gottdiener JS, Hetzel SJ, McMurray JJ, Komajda M, McKelvie R, Baicu CF, Massie BM, Carson PE; I-PRESERVE Investigators. Prevalence and significance of alterations in cardiac structure and function in patients with heart failure and a preserved ejection fraction. Circulation. 2011 Dec 6;124(23):2491-501. doi: 10.1161/CIRCULATIONAHA.110.011031. Epub 2011 Nov 7.
PMID: 22064591DERIVEDKrum H, Elsik M, Schneider HG, Ptaszynska A, Black M, Carson PE, Komajda M, Massie BM, McKelvie RS, McMurray JJ, Zile MR, Anand IS. Relation of peripheral collagen markers to death and hospitalization in patients with heart failure and preserved ejection fraction: results of the I-PRESERVE collagen substudy. Circ Heart Fail. 2011 Sep;4(5):561-8. doi: 10.1161/CIRCHEARTFAILURE.110.960716. Epub 2011 Jul 12.
PMID: 21750125DERIVEDAnand IS, Rector TS, Cleland JG, Kuskowski M, McKelvie RS, Persson H, McMurray JJ, Zile MR, Komajda M, Massie BM, Carson PE. Prognostic value of baseline plasma amino-terminal pro-brain natriuretic peptide and its interactions with irbesartan treatment effects in patients with heart failure and preserved ejection fraction: findings from the I-PRESERVE trial. Circ Heart Fail. 2011 Sep;4(5):569-77. doi: 10.1161/CIRCHEARTFAILURE.111.962654. Epub 2011 Jun 29.
PMID: 21715583DERIVEDHaass M, Kitzman DW, Anand IS, Miller A, Zile MR, Massie BM, Carson PE. Body mass index and adverse cardiovascular outcomes in heart failure patients with preserved ejection fraction: results from the Irbesartan in Heart Failure with Preserved Ejection Fraction (I-PRESERVE) trial. Circ Heart Fail. 2011 May;4(3):324-31. doi: 10.1161/CIRCHEARTFAILURE.110.959890. Epub 2011 Feb 24.
PMID: 21350053DERIVEDKomajda M, Carson PE, Hetzel S, McKelvie R, McMurray J, Ptaszynska A, Zile MR, Demets D, Massie BM. Factors associated with outcome in heart failure with preserved ejection fraction: findings from the Irbesartan in Heart Failure with Preserved Ejection Fraction Study (I-PRESERVE). Circ Heart Fail. 2011 Jan;4(1):27-35. doi: 10.1161/CIRCHEARTFAILURE.109.932996. Epub 2010 Nov 10.
PMID: 21068341DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- BMS Study Director
- Organization
- Britol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
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
November 1, 2004
First Posted
November 2, 2004
Study Start
June 1, 2002
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
April 7, 2015
Results First Posted
June 8, 2010
Record last verified: 2015-03