drugset / Trial / NCT01870778
Efficacy, Safety and Tolerability of Serelaxin When Added to Standard Therapy in AHF
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2013-10-02
- Primary completion
- 2017-01-23
- Completion
- 2017-02-01
Outcome
Missed primary endpoint
registry NUMBER Serelaxin (RLX030): 8.7 Percentage of participants NUMBER Placebo: 8.9 Percentage of participants analysis (superiority test); Serelaxin (RLX030) vs Placebo; p = 0.3857 NCT01870778 ↗
registry NUMBER Serelaxin (RLX030): 6.9 Percentage of participants NUMBER Placebo: 7.7 Percentage of participants analysis (superiority test); Serelaxin (RLX030) vs Placebo; p = 0.0968 NCT01870778 ↗
paper an infusion of serelaxin did not result in a lower incidence of death from cardiovascular causes at 180 days or worsening heart failure at 5 days than placebo. PMID 31433919 ↗
release “Phase III RELAX-AHF-2 study did not meet primary endpoints of reduced cardiovascular death or worsening heart failure in patients with acute heart failure” novartis.com ↗
Publications
- Venema CS, Metra M, Staal L, Beldhuis IE, Cotter G, Davison BA, Felker GM, Filippatos G, Greenberg BH, Pang PS, Ponikowski P, Gimpelewicz C, Lipsic E, Voors AA, Teerlink JR, Wykrzykowska JJ. Impact of Mild and Moderate Aortic Stenosis in Acute Heart Failure: Insights From RELAX-AHF-2. J Card Fail. 2026 Feb;32(2):419-429. doi: 10.1016/j.cardfail.2025.07.017. Epub 2025 Sep 1.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Serelaxin | Protein / enzyme biologic | 30 ug/kg | Intravenous |