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

A Phase II/III, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Relaxin in Subjects With Acute Heart Failure

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

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.

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