Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in AHF
RELAX-AHF-2
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in Acute Heart Failure Patients
2 other identifiers
interventional
6,600
34 countries
530
Brief Summary
The purpose of the study was to evaluate the efficacy, safety and tolerability of intravenous infusion of serelaxin, when added to standard therapy, in acute heart failure (AHF) patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2013
Typical duration for phase_3
530 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
June 3, 2013
CompletedFirst Posted
Study publicly available on registry
June 6, 2013
CompletedStudy Start
First participant enrolled
October 2, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 23, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedResults Posted
Study results publicly available
March 30, 2018
CompletedMarch 30, 2018
March 1, 2018
3.3 years
June 3, 2013
January 18, 2018
March 2, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Confirmed Cardiovascular (CV) Death Through Day 180
The percentage of participants with an adjudicated CV death through day 180 was assessed.
180 days
Percentage of Participants With Worsening of Heart Failure (WHF) Through Day 5
The percentage of participants with WHF through day 5 was assessed.
Day 5
Secondary Outcomes (8)
Percentage of Participants With All-cause Death Through Day 180
180 days
Length of Total Hospital Stay (LOS) During the Index Acute Heart Failure (AHF) Hospitalization
180 days (Participants still in the hospital at Day 60 were censored at Day 60)
Percentage of Participants With First Occurrence of Adjudicated CV Death or Adjudicated Re-hospitalization
180 days
Length of Intensive Care Unit (ICU) and/or Coronary Care Unit (CCU) Stay for the Index AHF Hospitalization
180 days (Patients still in the hospital at Day 60 were censored at Day 60)
Percentage of Participants With First Improvement Since Baseline in Congestive Signs and Symptoms of Heart Failure
From baseline to Day 5
- +3 more secondary outcomes
Study Arms (2)
Serelaxin (RLX030)
EXPERIMENTALParticipants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
Placebo
PLACEBO COMPARATORParticipants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
Interventions
Eligibility Criteria
You may qualify if:
- Male or female 18 years of age, with body weight ≤160 kg
- Hospitalized for AHF with anticipated requirement of IV therapy for at least 48 hours; AHF is defined as including all of the following measured at any time between presentation (including the emergency department) and the end of screening:
- Persistent dyspnea at rest or with minimal exertion
- Pulmonary congestion on chest radiograph
- B-type natriuretic peptide (BNP) ≥500 pg/mL or N-terminal (NT)-proBNP ≥2000 pg/mL; for patients ≥ 75 years of age or with current atrial fibrillation (at the time of randomization), BNP ≥ 750 pg/mL or NT-proBNP ≥ 3,000 pg/mL
- Systolic BP ≥125 mmHg at the start and at the end of screening
- Able to be randomized within 16 hours from presentation to the hospital, including the emergency department
- Received intravenous furosemide of at least 40 mg total (or equivalent) at any time between presentation (this includes outpatient clinic, ambulance, or hospital including emergency department) and the start of screening for the study for the treatment of the current acute HF episode.
You may not qualify if:
- Dyspnea primarily due to non-cardiac causes
- Known history of respiratory disorders requiring the daily use of IV or oral steroids (does not include inhaled steroids); need for intubation or the current use of IV or oral steroids for chronic obstructive pulmonary disease (COPD)
- Temperature \>38.5°C (oral or equivalent) or sepsis or active infection requiring IV anti-microbial treatment
- Clinical evidence of acute coronary syndrome currently or within 30 days prior to enrollment.
- AHF due to significant arrhythmias, which include any of the following: sustained ventricular tachycardia, bradycardia with sustained ventricular rate \<45 beats per minute, or atrial fibrillation/flutter with sustained ventricular response of \>130 beats per minute
- Patients with severe renal impairment defined as pre-randomization estimated glomerular filtration rate (eGFR) \< 25 mL/min/1.73m2 calculated using the Simplified Modification of Diet in Renal Disease (sMDRD) equation, and/or those receiving current or planned dialysis or ultrafiltration
- Patients with hematocrit \<25%, or a history of blood transfusion within the 14 days prior to screening, or active life-threatening GI bleeding.
- Known hepatic impairment (as evidenced by total bilirubin \> 3 mg/dL, or increased ammonia levels, if performed) or history of cirrhosis with evidence of portal hypertension such as varices.
- Significant, uncorrected, left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy or severe aortic stenosis (i.e., aortic valve area \<1.0 cm2 or mean gradient \>40 mmHg on prior or current echocardiogram), and severe mitral stenosis
- Severe aortic insufficiency or severe mitral regurgitation for which surgical or percutaneous intervention is indicated.
- Documented, prior to or at the time of randomization, restrictive amyloid myocardiopathy, OR acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (does NOT include restrictive mitral filling patterns seen on Doppler echocardiographic assessments of diastolic function).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (540)
Novartis Investigative Site
Huntsville, Alabama, 35801, United States
Novartis Investigative Site
Montgomery, Alabama, 36106, United States
Novartis Investigative Site
Tucson, Arizona, 85723-0001, United States
Novartis Investigative Site
Anaheim, California, 92801, United States
Novartis Investigative Site
Fresno, California, 93720, United States
Novartis Investigative Site
Loma Linda, California, 92354, United States
Novartis Investigative Site
Los Angeles, California, 90033, United States
Novartis Investigative Site
Los Angeles, California, 90073, United States
Novartis Investigative Site
Los Angeles, California, 90095, United States
Novartis Investigative Site
Northridge, California, 91325, United States
Novartis Investigative Site
Palo Alto, California, 94304-1207, United States
Novartis Investigative Site
Sacramento, California, 95817-1460, United States
Novartis Investigative Site
San Diego, California, 92103, United States
Novartis Investigative Site
San Diego, California, 92123, United States
Novartis Investigative Site
San Diego, California, 92161, United States
Novartis Investigative Site
Sylmar, California, 91342, United States
Novartis Investigative Site
Walnut Creek, California, 94598, United States
Novartis Investigative Site
Colorado Springs, Colorado, 80909, United States
Novartis Investigative Site
Denver, Colorado, 80204-4507, United States
Novartis Investigative Site
Hartford, Connecticut, 06102, United States
Novartis Investigative Site
Hartford, Connecticut, 06105, United States
Novartis Investigative Site
Atlantis, Florida, 33462, United States
Novartis Investigative Site
Jacksonville, Florida, 32207, United States
Novartis Investigative Site
Jacksonville, Florida, 32209, United States
Novartis Investigative Site
Jacksonville, Florida, 32216, United States
Novartis Investigative Site
Sanford, Florida, 32771, United States
Novartis Investigative Site
Sarasota, Florida, 34239, United States
Novartis Investigative Site
Tampa, Florida, 33606, United States
Novartis Investigative Site
Tampa, Florida, 33612, United States
Novartis Investigative Site
Winter Haven, Florida, 33881, United States
Novartis Investigative Site
Atlanta, Georgia, 30310, United States
Novartis Investigative Site
Atlanta, Georgia, 30342, United States
Novartis Investigative Site
Marietta, Georgia, 30060, United States
Novartis Investigative Site
Chicago, Illinois, 60637, United States
Novartis Investigative Site
Elk Grove Village, Illinois, 60007, United States
Novartis Investigative Site
Oakbrook Terrace, Illinois, 60181, United States
Novartis Investigative Site
Peoria, Illinois, 61602, United States
Novartis Investigative Site
Indianapolis, Indiana, 46202-5111, United States
Novartis Investigative Site
Indianapolis, Indiana, 46237, United States
Novartis Investigative Site
Muncie, Indiana, 47303-3400, United States
Novartis Investigative Site
Kansas City, Kansas, 66160, United States
Novartis Investigative Site
Alexandria, Louisiana, 71301, United States
Novartis Investigative Site
Baton Rouge, Louisiana, 70808, United States
Novartis Investigative Site
Covington, Louisiana, 70433, United States
Novartis Investigative Site
New Orleans, Louisiana, 70112, United States
Novartis Investigative Site
Annapolis, Maryland, 21401, United States
Novartis Investigative Site
Baltimore, Maryland, 21201, United States
Novartis Investigative Site
Baltimore, Maryland, 21287, United States
Novartis Investigative Site
Boston, Massachusetts, 02114, United States
Novartis Investigative Site
Boston, Massachusetts, 02115, United States
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Boston, Massachusetts, United States
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Worcester, Massachusetts, 01655, United States
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Detroit, Michigan, 48201, United States
Novartis Investigative Site
Detroit, Michigan, 48202, United States
Novartis Investigative Site
Detroit, Michigan, 48235, United States
Novartis Investigative Site
Minneapolis, Minnesota, 55417, United States
Novartis Investigative Site
Jackson, Mississippi, 39216, United States
Novartis Investigative Site
Picayune, Mississippi, 39466, United States
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Kansas City, Missouri, 64108, United States
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St Louis, Missouri, 63110, United States
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St Louis, Missouri, 63128, United States
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St Louis, Missouri, 63136, United States
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Omaha, Nebraska, 68198, United States
Novartis Investigative Site
Brooklyn, New York, 11203, United States
Novartis Investigative Site
Brooklyn, New York, 11215, United States
Novartis Investigative Site
Kingston, New York, 12401, United States
Novartis Investigative Site
New Hyde Park, New York, 11040, United States
Novartis Investigative Site
Rochester, New York, 14642, United States
Novartis Investigative Site
Stony Brook, New York, 11794, United States
Novartis Investigative Site
The Bronx, New York, 10461, United States
Novartis Investigative Site
The Bronx, New York, 10467-2490, United States
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Chapel Hill, North Carolina, 27599-7075, United States
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Durham, North Carolina, 27710, United States
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Raleigh, North Carolina, 27610, United States
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Canton, Ohio, 44710, United States
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Cincinnati, Ohio, 45220, United States
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Cincinnati, Ohio, 45267-0585, United States
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Cleveland, Ohio, 44195, United States
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Columbus, Ohio, 43210, United States
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Toledo, Ohio, 43614, United States
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Portland, Oregon, 97219, United States
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Abington, Pennsylvania, 19001, United States
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Natrona Heights, Pennsylvania, 15065, United States
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Philadelphia, Pennsylvania, 19102 2293, United States
Novartis Investigative Site
Philadelphia, Pennsylvania, 19107, United States
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Wynnewood, Pennsylvania, 19096, United States
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Providence, Rhode Island, 02903, United States
Novartis Investigative Site
Warwick, Rhode Island, 02886, United States
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Greenville, South Carolina, 29607, United States
Novartis Investigative Site
Greenville, South Carolina, 29615, United States
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Nashville, Tennessee, 37203, United States
Novartis Investigative Site
Nashville, Tennessee, 37212, United States
Novartis Investigative Site
Dallas, Texas, 75216, United States
Novartis Investigative Site
Dallas, Texas, 75226, United States
Novartis Investigative Site
Galveston, Texas, 77555, United States
Novartis Investigative Site
Houston, Texas, 77030, United States
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San Antonio, Texas, 78229, United States
Novartis Investigative Site
San Antonio, Texas, 78234, United States
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Charlottesville, Virginia, 22908, United States
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Falls Church, Virginia, 22042, United States
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Lynchburg, Virginia, 24501, United States
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Roanoke, Virginia, 24014, United States
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Seattle, Washington, 98101, United States
Novartis Investigative Site
Seattle, Washington, 98122, United States
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Morgantown, West Virginia, 26506, United States
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CABA, Buenos Aires, C1180AAX, Argentina
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Caba, Buenos Aires, C1280AEB, Argentina
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Carapachay, Buenos Aires, B1605, Argentina
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Coronel Suárez, Buenos Aires, B7540GHD, Argentina
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La Plata, Buenos Aires, B1900AWT, Argentina
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San Martín, Buenos Aires, B1650CSQ, Argentina
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San Salvador de Jujuy, Jujuy Province, Y4600ABF, Argentina
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Rosario, Santa Fe Province, C2000DSR, Argentina
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Rosario, Santa Fe Province, S2000DSV, Argentina
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Rosario, Santa Fe Province, S2001ODA, Argentina
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Rosario, Santa Fe Province, S2001SBL, Argentina
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San Miguel de Tucumán, Tucumán Province, T4000JCU, Argentina
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Buenos Aires, B1602ABQ, Argentina
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Buenos Aires, B1846BMF, Argentina
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Buenos Aires, C1039AAP, Argentina
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Buenos Aires, C1120AAF, Argentina
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Buenos Aires, C1405CNF, Argentina
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Buenos Aires, C1425AGP, Argentina
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Buenos Aires, C1428DCO, Argentina
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Buenos Aires, W3400ABH, Argentina
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Corrientes, W3400CBI, Argentina
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Corrientes, W3400, Argentina
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Córdoba, X5000AAX, Argentina
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Córdoba, X5000EPU, Argentina
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Córdoba, X5004BAL, Argentina
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Córdoba, X5004CDT, Argentina
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Córdoba, X5006IKK, Argentina
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Córdoba, X5009BSN, Argentina
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Córdoba, X5016KET, Argentina
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Formosa, P3600, Argentina
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Salta, A4400, Argentina
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San Miguel de Tucumán, T4000NIJ, Argentina
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Santa Fe, S3000EOZ, Argentina
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Santa Fe, S3000FUJ, Argentina
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Camperdown, New South Wales, 2050, Australia
Novartis Investigative Site
Concord, New South Wales, 2139, Australia
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Randwick, New South Wales, 2031, Australia
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St Leonards, New South Wales, 2065, Australia
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Herston, Queensland, 4029, Australia
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Bedford Park, South Australia, 5041, Australia
Novartis Investigative Site
Geelong, Victoria, 3220, Australia
Novartis Investigative Site
Melbourne, Victoria, 3004, Australia
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Murdoch, Western Australia, 6150, Australia
Novartis Investigative Site
Perth, Western Australia, 6000, Australia
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Innsbruck, Tyrol, 6020, Austria
Novartis Investigative Site
Braunau am Inn, A5280, Austria
Novartis Investigative Site
Graz, A-8036, Austria
Novartis Investigative Site
Linz, 4010, Austria
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Linz, A-4010, Austria
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Salzburg, Austria
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Vienna, A-1090, Austria
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Villach, 9500, Austria
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Wels, 4600, Austria
Novartis Investigative Site
Aalst, 9300, Belgium
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Brussels, 1200, Belgium
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Brussels, B-1070, Belgium
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Genk, 3600, Belgium
Novartis Investigative Site
Ghent, 9000, Belgium
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Kortrijk, 8500, Belgium
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Leuven, 3000, Belgium
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Mons, 7000, Belgium
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Goiânia, Goiás, 74605-020, Brazil
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Curitiba, Paraná, 80730 150, Brazil
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Rio de Janeiro, Rio de Janeiro, 20551-030, Brazil
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90035-003, Brazil
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Porto Alegre, Rio Grande do Sul, 90880-480, Brazil
Novartis Investigative Site
Ribeirão Preto, São Paulo, 14048-900, Brazil
Novartis Investigative Site
São José do Rio Preto, São Paulo, 15090-000, Brazil
Novartis Investigative Site
São Paulo, São Paulo, 04012 909, Brazil
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São Paulo, São Paulo, 05303-000, Brazil
Novartis Investigative Site
Smolyan, Bulgaria, 4700, Bulgaria
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Pazardzhik, 4400, Bulgaria
Novartis Investigative Site
Pleven, 5800, Bulgaria
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Plovdiv, 4002, Bulgaria
Novartis Investigative Site
Sofia, 1202, Bulgaria
Novartis Investigative Site
Sofia, 1407, Bulgaria
Novartis Investigative Site
Sofia, 1527, Bulgaria
Novartis Investigative Site
Sofia, 1606, Bulgaria
Novartis Investigative Site
Sofia, 1709, Bulgaria
Novartis Investigative Site
Varna, 9010, Bulgaria
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Calgary, Alberta, T2N 4Z6, Canada
Novartis Investigative Site
Toronto, Ontario, M5B 1N9, Canada
Novartis Investigative Site
Montreal, Quebec, H1T 1C8, Canada
Novartis Investigative Site
Sainte-Foy, Quebec, G1V 4G5, Canada
Novartis Investigative Site
Thetford-Mines, Quebec, G6G 2V4, Canada
Novartis Investigative Site
Las Condes, Santiago Metropolitan, 7560171, Chile
Novartis Investigative Site
Santiago, Chile
Novartis Investigative Site
Medellín, Antioquia, 050036, Colombia
Novartis Investigative Site
Barranquilla, Colombia
Novartis Investigative Site
Florida Blanca, Colombia
Novartis Investigative Site
Brno-Bohunice, Czech Republic, 625 00, Czechia
Novartis Investigative Site
Frýdek-Místek, Czech Republic, 73801, Czechia
Novartis Investigative Site
Kladno, Czech Republic, 272 00, Czechia
Novartis Investigative Site
Liberec, Czech Republic, 46063, Czechia
Novartis Investigative Site
Pardubice, Czech Republic, 532 03, Czechia
Novartis Investigative Site
Prague, Czech Republic, 169 02, Czechia
Novartis Investigative Site
Slaný, Czech Republic, 27401, Czechia
Novartis Investigative Site
Ústí nad Labem, Czech Republic, 400 11, Czechia
Novartis Investigative Site
Ústí nad Orlicí, Czech Republic, 562 18, Czechia
Novartis Investigative Site
Zlín, Czech Republic, 76275, Czechia
Novartis Investigative Site
Hradec Králové, CZE, 500 05, Czechia
Novartis Investigative Site
Benešov, 25601, Czechia
Novartis Investigative Site
Brno, 636 00, Czechia
Novartis Investigative Site
Jihlava, 586 01, Czechia
Novartis Investigative Site
Kolín, 280 20, Czechia
Novartis Investigative Site
Pilsen, 301 00, Czechia
Novartis Investigative Site
Prague, 100 34, Czechia
Novartis Investigative Site
Prague, 12808, Czechia
Novartis Investigative Site
Copenhagen NV, DK-2400, Denmark
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Glostrup Municipality, 2600, Denmark
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Glostrup Municipality, DK-2600, Denmark
Novartis Investigative Site
Randers, 8930, Denmark
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Amiens, 80054, France
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Besançon, 25030, France
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Béziers, 34525, France
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Bobigny, 93009, France
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Caen, 14000, France
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Chambray-lès-Tours, 37170, France
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La Tronche, 38700, France
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Le Chesnay, 78157, France
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Le Chesnay, France
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Lille, 59037, France
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Lille, 59042, France
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Nancy, 54035, France
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Paris, 75010, France
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Paris, 75015, France
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Paris, 75877, France
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Pessac, 33604, France
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Pontoise, F-95300, France
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Rouen, 76000, France
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Saint Herblain - Nantes, 44093, France
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Toulouse, 31054, France
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Tourcoing, 59208, France
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Cologne, North Rhine-Westphalia, 50937, Germany
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Bad Krozingen, 79189, Germany
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Berlin, 10117, Germany
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Berlin, 12203, Germany
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Berlin, 12621, Germany
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Berlin, 13347, Germany
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Berlin, 13353, Germany
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Berlin, 13509, Germany
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Berlin, 13578, Germany
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Bitburg, 54634, Germany
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Bochum, 44791, Germany
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Bonn, 53105, Germany
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Bonn, 53115, Germany
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Brandenburg, 16321, Germany
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Bremen, 28277, Germany
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Coburg, 96450, Germany
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Detmold, 32756, Germany
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Dortmund, 44137, Germany
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Dortmund, 44379, Germany
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Dresden, 01067, Germany
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Erfurt, 99084, Germany
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Erfurt, 99089, Germany
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Essen, 45122, Germany
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Essen, 45356, Germany
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Frankfurt, 60488, Germany
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Frankfurt, 60590, Germany
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Frankfurt, 65929, Germany
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Freiburg im Breisgau, 79106, Germany
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Friedberg, 86316, Germany
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Füssen, 87629, Germany
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Göttingen, 37073, Germany
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Göttingen, 37075, Germany
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Greifswald, 17475, Germany
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Halle, 06120, Germany
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Hamburg, 20246, Germany
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Hamburg, 22291, Germany
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Heilbronn, 74078, Germany
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Jena, 07740, Germany
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Kiel, 24105, Germany
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Kleve, 47533, Germany
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Koeln-Nippes, 50733, Germany
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Langen, 63225, Germany
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Leipzig, 04103, Germany
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Leverkusen, 51375, Germany
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Limburg, 65549, Germany
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Ludwigshafen, 67063, Germany
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Lübeck, 23569, Germany
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Magdeburg, 39104, Germany
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Magdeburg, 39120, Germany
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Mainz, 55131, Germany
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Merseburg, 06217, Germany
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Mönchengladbach, 41063, Germany
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München, 80636, Germany
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Neuwied, 56564, Germany
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Oldenburg, 26133, Germany
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Regensburg, 93053, Germany
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Rüsselsheim am Main, 65428, Germany
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Tübingen, 72076, Germany
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Ulm, 89081, Germany
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Villingen-Schwenningen, 78052, Germany
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Weiden, 92637, Germany
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Witten, 58455, Germany
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Wuppertal, 42117, Germany
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Würzburg, 97078, Germany
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Zwickau, 08060, Germany
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Athens, GR, 14233, Greece
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Larissa, GR, 411 10, Greece
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Athens, 11526, Greece
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Athens, 11528, Greece
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Chaïdári, 12461, Greece
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Thessaloniki, GR 54636, Greece
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Balatonfüred, H-8231, Hungary
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Budapest, 1027, Hungary
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Budapest, 1043, Hungary
Novartis Investigative Site
Budapest, 1085, Hungary
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Budapest, 1106, Hungary
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Budapest, 1125, Hungary
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Budapest, 1134, Hungary
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Budapest, 1145, Hungary
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Budapest, H 1096, Hungary
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Cegléd, 2700, Hungary
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Debrecen, 4032, Hungary
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Kaposvár, 7400, Hungary
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Mátészalka, 4700, Hungary
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Pécs, 7624, Hungary
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Székesfehérvár, H-8000, Hungary
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Szombathely, 9700, Hungary
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Zalaegerszeg, 8900, Hungary
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Dublin, 4, Ireland
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Dublin, Ireland
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Galway, Ireland
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Lower Galilee, Israel, 15208, Israel
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Ashkelon, 78278, Israel
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Related Publications (8)
Ravera A, Qin H, Ter Maaten JM, Santema BT, Adamo M, Ponikowski P, Cotter G, Davison BA, Felker GM, Filippatos GS, Pang PS, Greenberg BH, Gimpelewicz C, Severin T, Teerkink JR, Voors AA, Metra M. Clinical Presentation, Biomarker Trajectories, and Outcomes in Women and Men Hospitalized for Acute Heart Failure. JACC Heart Fail. 2025 Oct;13(10):102524. doi: 10.1016/j.jchf.2025.102524. Epub 2025 Aug 21.
PMID: 40845614DERIVEDPagnesi M, Staal L, Ter Maaten JM, Beldhuis IE, Cotter G, Davison BA, Jongs N, Felker GM, Filippatos G, Greenberg BH, Pang PS, Ponikowski P, Lombardi CM, Adamo M, Severin T, Gimpelewicz C, Voors AA, Teerlink JR, Metra M. Decongestion and Outcomes in Patients Hospitalized for Acute Heart Failure: Insights From the RELAX-AHF-2 Trial. JACC Heart Fail. 2025 Mar;13(3):414-429. doi: 10.1016/j.jchf.2024.09.013. Epub 2024 Nov 27.
PMID: 39614837DERIVEDGrand J, Miger K, Sajadieh A, Kober L, Torp-Pedersen C, Ertl G, Lopez-Sendon J, Pietro Maggioni A, Teerlink JR, Sato N, Gimpelewicz C, Metra M, Holbro T, Nielsen OW. Blood Pressure Drops During Hospitalization for Acute Heart Failure Treated With Serelaxin: A Patient-Level Analysis of 4 Randomized Controlled Trials. Circ Heart Fail. 2022 Apr;15(4):e009199. doi: 10.1161/CIRCHEARTFAILURE.121.009199. Epub 2022 Feb 21.
PMID: 35184572DERIVEDMatsue Y, Sama IE, Postmus D, Metra M, Greenberg BH, Cotter G, Davison BA, Felker GM, Filippatos G, Pang P, Ponikowski P, Severin T, Gimpelewicz C, Voors AA, Teerlink JR. Association of Early Blood Pressure Decrease and Renal Function With Prognosis in Acute Heart Failure. JACC Heart Fail. 2021 Dec;9(12):890-903. doi: 10.1016/j.jchf.2021.07.001. Epub 2021 Oct 6.
PMID: 34627724DERIVEDGrand J, Miger K, Sajadieh A, Kober L, Torp-Pedersen C, Ertl G, Lopez-Sendon J, Pietro Maggioni A, Teerlink JR, Sato N, Gimpelewicz C, Metra M, Holbro T, Nielsen OW. Systolic Blood Pressure and Outcome in Patients Admitted With Acute Heart Failure: An Analysis of Individual Patient Data From 4 Randomized Clinical Trials. J Am Heart Assoc. 2021 Sep 21;10(18):e022288. doi: 10.1161/JAHA.121.022288. Epub 2021 Sep 13.
PMID: 34514815DERIVEDLoungani RS, Teerlink JR, Metra M, Allen LA, Butler J, Carson PE, Chen CW, Cotter G, Davison BA, Eapen ZJ, Filippatos GS, Gimpelewicz C, Greenberg B, Holbro T, Januzzi JL Jr, Lanfear DE, Pang PS, Pina IL, Ponikowski P, Miller AB, Voors AA, Felker GM. Cause of Death in Patients With Acute Heart Failure: Insights From RELAX-AHF-2. JACC Heart Fail. 2020 Dec;8(12):999-1008. doi: 10.1016/j.jchf.2020.09.010. Epub 2020 Nov 11.
PMID: 33189635DERIVEDMetra M, Teerlink JR, Cotter G, Davison BA, Felker GM, Filippatos G, Greenberg BH, Pang PS, Ponikowski P, Voors AA, Adams KF, Anker SD, Arias-Mendoza A, Avendano P, Bacal F, Bohm M, Bortman G, Cleland JGF, Cohen-Solal A, Crespo-Leiro MG, Dorobantu M, Echeverria LE, Ferrari R, Goland S, Goncalvesova E, Goudev A, Kober L, Lema-Osores J, Levy PD, McDonald K, Manga P, Merkely B, Mueller C, Pieske B, Silva-Cardoso J, Spinar J, Squire I, Stepinska J, Van Mieghem W, von Lewinski D, Wikstrom G, Yilmaz MB, Hagner N, Holbro T, Hua TA, Sabarwal SV, Severin T, Szecsody P, Gimpelewicz C; RELAX-AHF-2 Committees Investigators. Effects of Serelaxin in Patients with Acute Heart Failure. N Engl J Med. 2019 Aug 22;381(8):716-726. doi: 10.1056/NEJMoa1801291.
PMID: 31433919DERIVEDTeerlink JR, Voors AA, Ponikowski P, Pang PS, Greenberg BH, Filippatos G, Felker GM, Davison BA, Cotter G, Gimpelewicz C, Boer-Martins L, Wernsing M, Hua TA, Severin T, Metra M. Serelaxin in addition to standard therapy in acute heart failure: rationale and design of the RELAX-AHF-2 study. Eur J Heart Fail. 2017 Jun;19(6):800-809. doi: 10.1002/ejhf.830. Epub 2017 Apr 28.
PMID: 28452195DERIVED
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
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2013
First Posted
June 6, 2013
Study Start
October 2, 2013
Primary Completion
January 23, 2017
Study Completion
February 1, 2017
Last Updated
March 30, 2018
Results First Posted
March 30, 2018
Record last verified: 2018-03