Efficacy and Safety of Relaxin for the Treatment of Acute Heart Failure (RELAX-AHF)

Corthera

Status and phase: Completed; Phase 3; Phase 2

Conditions: Heart Failure, Congestive

Treatments: Drug: Relaxin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00520806

RLX.CHF.003

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,161 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,161 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

48 hour iv infusion of placebo

Treatment:

Drug: Placebo

Relaxin

Experimental group

Description:

48 hour iv infusion of relaxin at 30 ug/kg/day

Treatment:

Drug: Relaxin