Efficacy and Safety of Relaxin for the Treatment of Acute Heart Failure
- Registration Number
- NCT00520806
- Lead Sponsor
- Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1161
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo 48 hour iv infusion of placebo Relaxin Relaxin 48 hour iv infusion of relaxin at 30 ug/kg/day
- Primary Outcome Measures
Name Time Method Relief of dyspnea in acute heart failure Up to day 5
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (3)
Heart Institute
🇮🇱Safed, Israel
Northwestern University
🇺🇸Chicago, Illinois, United States
Wayne State University/Detroit Receiving Hospital
🇺🇸Detroit, Michigan, United States