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

Official Title: “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.

Intervention(s) in this Clinical Trial

• Drug: Relaxin
  • Intravenous infusion for 48 h at 30 ug/kg/day
• Drug: Placebo
  • Intravenous infusion for 48 h

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: Placebo
  • 48 hour iv infusion of placebo
• Experimental: Relaxin
  • 48 hour iv infusion of relaxin at 30 ug/kg/day

Primary Measures

• Relief of dyspnea in acute heart failure
  • Time Frame: Up to day 5
    Safety Issue?: No

Secondary Measures

• Days alive and out of hospital
  • Time Frame: Up to day 60
    Safety Issue?: No
• CV death or rehospitalization due to heart failure or renal failure
  • Time Frame: Up to day 60
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Corthera, Inc. Industry

Overall Clinical Trial Officials and Contacts

Thomas Severin, MD Study Director Novartis Pharmaceuticals  

Overall Contact: Elaine Unemori, PhD 650.235.3568 

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00520806

Study ID Number: RLX.CHF.003

ClinicalTrials.gov Identifier: NCT00520806

Health Authority: United States: Food and Drug Administration