Efficacy and Safety of Relaxin for the Treatment of Acute Heart Failure

Conditions

Heart Failure, Congestive

Keywords

Heart failure, Renal dysfunction, Relaxin, Vasodilator

Brief summary

Different doses of relaxin will be compared to placebo to determine efficacy and safety for the treatment of patients hospitalized with acute heart failure

Detailed description

This is an international, randomized, double-blind, placebo-controlled, Phase II/III trial of intravenous recombinant relaxin for the treatment of signs and symptoms in patients hospitalized for acute decompensated heart failure. The Phase II pilot study has completed; the Phase III main portion of the trial is ongoing.

Johannes Grand, Kristina Miger, Ahmad Sajadieh, Lars Køber, Christian Torp‐Pedersen et al. (14 authors)

Circulation Heart Failure2022-02-216 citations

10.1161/circheartfailure.121.009199

Sex differences in early dyspnea relief between men and women hospitalized for acute heart failure: insights from the RELAX-AHF study.

Meyer S, Teerlink JR, Metra M, Ponikowski P, Cotter G, Davison BA, Felker GM, Filippatos G, Greenberg BH, Hua TA, Severin T, Qian M, Voors AA.

2016-11-1217 citations

10.1007/s00392-016-1051-4

Diuretic Response in Patients with Acute Decompensated Heart Failure: Characteristics and Clinical Outcome—an Analysis from RELAX-AHF

Adriaan A. Voors, Beth A. Davison, John R. Teerlink, G. Michael Felker, Gad Cotter et al. (14 authors)

European Journal of Heart Failure2014-10-07150 citations

10.1002/ejhf.170

Effect of serelaxin on mode of death in acute heart failure: results from the RELAX-AHF study.

Felker GM, Teerlink JR, Butler J, Hernandez AF, Miller AB, Cotter G, Davison BA, Filippatos G, Greenberg BH, Ponikowski P, Voors AA, Hua TA, Severin TM, Unemori E, Metra M.

2014-10-0149 citations

10.1016/j.jacc.2014.05.071

Serelaxin, recombinant human relaxin-2, for treatment of acute heart failure (RELAX-AHF): a randomised, placebo-controlled trial.

Teerlink JR, Cotter G, Davison BA, Felker GM, Filippatos G, Greenberg BH, Ponikowski P, Unemori E, Voors AA, Adams KF, Dorobantu MI, Grinfeld LR, Jondeau G, Marmor A, Masip J, Pang PS, Werdan K, Teichman SL, Trapani A, Bush CA, Saini R, Schumacher C, Severin TM, Metra M, RELAXin in Acute Heart Failure (RELAX-AHF) Investigators.

2012-11-07677 citations

10.1016/s0140-6736(12)61855-8

Early drop in systolic blood pressure and worsening renal function in acute heart failure: renal results of Pre-RELAX-AHF.

Voors AA, Davison BA, Felker GM, Ponikowski P, Unemori E, Cotter G, Teerlink JR, Greenberg BH, Filippatos G, Teichman SL, Metra M, Pre-RELAX-AHF study group.

2011-05-2889 citations

10.1093/eurjhf/hfr060

Relaxin for the treatment of patients with acute heart failure (Pre-RELAX-AHF): a multicentre, randomised, placebo-controlled, parallel-group, dose-finding phase IIb study.

Teerlink JR, Metra M, Felker GM, Ponikowski P, Voors AA, Weatherley BD, Marmor A, Katz A, Grzybowski J, Unemori E, Teichman SL, Cotter G.

2009-03-28311 citations

10.1016/s0140-6736(09)60622-x

Interventions

DRUGRelaxin

Intravenous infusion for 48 h at 30 ug/kg/day

DRUGPlacebo

Intravenous infusion for 48 h

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Hospitalized for acute heart failure * Dyspnea at rest or with minimal exertion * Pulmonary congestion * Able to provide informed consent * Systolic blood pressure \> 125 mmHg * Impaired renal function defined as an eGFR of 30-75 mL/min/1.73m2

Exclusion criteria

* Use of other IV therapies for acute heart failure * Fever or sepsis * Recent major neurologic event * Recent major surgery * Recent acute coronary syndrome * Other recent investigational drug use

Design outcomes

Primary

Measure	Time frame
Relief of dyspnea in acute heart failure	Up to day 5

Secondary

Measure	Time frame
Days alive and out of hospital	Up to day 60
CV death or rehospitalization due to heart failure or renal failure	Up to day 60

Countries

Israel, United States

Outcome results

None listed