Efficacy and Safety of Relaxin for the Treatment of Acute Heart Failure
Information source: BAS Medical
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heart Failure, Congestive
Intervention: Relaxin (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: BAS Medical Official(s) and/or principal investigator(s):
Sam Teichman, MD, Study Director, Affiliation: BAS Medical
Overall contact:
Sam Teichman, MD, Phone: 925.314.0569
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
Clinical Details
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
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Signs and symptoms of acute heart failure
Secondary outcome: Renal function
Detailed description:
This is an international, randomized, double-blind, placebo-controlled trial of intravenous
recombinant relaxin for the treatment of signs and symptoms in patients hospitalized for
acute decompensated heart failure. A pilot study will determine the optimum dose of relaxin
which will be studied further in the main portion of the trial.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Hospitalized for acute heart failure
- Dyspnea at rest or with minimal exertion
- Pulmonary congestion
- Able to provide informed consent
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
Locations and Contacts
Sam Teichman, MD, Phone: 925.314.0569
Heart Institute, Safed, Israel; Recruiting
Russian Cardiologic Research Complex, Moscow, Russian Federation; Recruiting
Northwestern University, Chicago, Illinois 60611, United States; Recruiting
Peter Pang
Wayne State University/Detroit Receiving Hospital, Detroit, Michigan 48201, United States; Recruiting
Phillip Levy
University of Cincinnati College of Medicine, Cincinnati, Ohio 45267, United States; Recruiting
Sean Collins
Additional Information
Starting date: October 2007
Last updated: June 30, 2008
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