Heart Failure, Congestive Clinical Trial
— RELAX-AHFOfficial 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
Status | Completed |
Enrollment | 1161 |
Est. completion date | September 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Heart Institute | Safed | |
United States | Northwestern University | Chicago | Illinois |
United States | Wayne State University/Detroit Receiving Hospital | Detroit | Michigan |
Lead Sponsor | Collaborator |
---|---|
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies |
United States, Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Relief of dyspnea in acute heart failure | Up to day 5 | No | |
Secondary | Days alive and out of hospital | Up to day 60 | No | |
Secondary | CV death or rehospitalization due to heart failure or renal failure | Up to day 60 | No |
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