Recombinant Human Relaxin for the Treatment of Decompensated CHF
Two doses of relaxin will be compared to placebo for the treatment of patients with decompensated...
Brief Summary
Official Title: “A Phase II Randomized, Double Blind, Placebo-Controlled Study of Recombinant Human Relaxin in Patients With Decompensated Congestive Heart Failure”
Two doses of relaxin will be compared to placebo for the treatment of patients with decompensated CHF
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Detailed Clinical Trial Description
Pilot clinical data suggest that recombinant human relaxin may be effective in treating patients with decompensated CHF. This study will randomize patients in blinded manner to one of two doses of intravenous relaxin or placebo. Serial evaluations will include cardiac and renal function, as well as safety and tolerability.
Intervention(s) in this Clinical Trial
- Drug: Recombinant human relaxin
Outcome Measures for this Clinical Trial
Primary Measures
- Cardiac hemodynamics
Secondary Measures
- Renal function
- Safety
- Tolerability
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Hospitalization
- Decompensated chronic CHF (NYHA Class III-IV)
- LVEF < 35%
- PCWP > 22 mmHg
- CI < 2.3 L/min/m2
Exclusion Criteria:
- Acute CHF
- Acute coronary syndrome
- Hypotension or shock
- Recent stroke
- Allergy or sensitivity to test agents
- Significant confounding conditions or medications
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 19 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Corthera, Inc. Industry
Overall Clinical Trial Officials and Contacts
Thomas Dschietzig, MD Principal Investigator Charite Hospital, Berlin, Germany
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00406575
Study ID Number: RLX.CHF.002
ClinicalTrials.gov Identifier: NCT00406575
Health Authority: Russia: Ministry of Health
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00406575
