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: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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

Primary Measures

• Cardiac hemodynamics

Secondary Measures

• Renal function
• Safety
• Tolerability

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

Lead Sponsor: BAS Medical

Overall Clinical Trial Officials and Contacts

Thomas Dschietzig, MD Principal Investigator Charite Hospital, Berlin, Germany  

Information obtained from ClinicalTrials.gov on August 28, 2008

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