Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in AHF
NCT ID: NCT01870778
Last Updated: 2018-03-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
6600 participants
INTERVENTIONAL
2013-10-02
2017-02-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Serelaxin (RLX030)
Participants received continuous intravenous infusion of serelaxin 30 ug/kg/day for 48 hours.
RLX030
1 mg/mL solution in 6 mL vials
Placebo
Participants received continuous intravenous infusion of matching placebo to serelaxin for 48 hours.
Placebo
Matching placebo solution to serelaxin
Interventions
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RLX030
1 mg/mL solution in 6 mL vials
Placebo
Matching placebo solution to serelaxin
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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References
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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 Aug 21;13(10):102524. doi: 10.1016/j.jchf.2025.102524. Online ahead of print.
Pagnesi 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.
Grand 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.
Matsue 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.
Grand 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.
Loungani 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.
Metra 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.
Teerlink 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.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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2013-001498-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CRLX030A2301
Identifier Type: -
Identifier Source: org_study_id
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