Effect of Serelaxin Versus Standard of Care in Acute Heart Failure (AHF) Patients

Summary

This was a multinational, multicenter, randomized, open-label study to confirm and expand the efficacy, safety and tolerability evidence of 48 hours intravenous infusion of serelaxin (30 micrograms/kg/day) when added to Standard of Care (SoC) in patients admitted to hospital for Acute Heart Failure (AHF).

Timeline

Start

2014-01-31

Primary completion

2017-03-26

Completion

2017-04-25

Outcome

Met primary endpoint

Stopped: “Study was terminated based on results from pivotal adult AHF study CRLX030A2301”

registry analysis (superiority test); Serelaxin + Standard of Care vs Standard of Care (SOC); p = 0.0172; Hazard Ratio (HR) 0.71 (95% CI 0.51 to 0.98) NCT02064868 ↗

Publications

• 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.
• 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Serelaxin	Protein / enzyme biologic	30 ug/kg	Intravenous

Indications