Official Title: “A Pilot Safety and Dose-Finding Trial of Intravenous Recombinant Human Relaxin (rhRlx) in Compensated Congestive Heart Failure”

This trial is a single center, open-label, dose-finding study of recombinant human relaxin (rhRlx) given intravenously (IV) to patients with stable, compensated CHF.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study

Serial cohorts of patients with stable CHF will be enrolled upon meeting eligibility criteria. Dose escalation will be guided by hemodynamic response, safety and tolerability.

The effects of rhRlx on hemodynamics will be assessed.

Intervention(s) in this Clinical Trial

• Drug: Relaxin

Primary Measures

• Cardiac hemodynamics including PCWP, CO/CI, SVR
  • Safety Issue?: No

Secondary Measures

• Safety and tolerability
  • Safety Issue?: Yes
• Tolerability

Inclusion Criteria:

• Male and female patients over the age of 18
• New York Heart Association (NYHA) Class II-III CHF
• Left Ventricular Ejection Fraction (LVEF) of < 35%

Exclusion Criteria:

• Acute coronary syndrome
• Acute decompensated CHF
• Hypotension
• Recent significant arrhythmia
• Recent stroke
• Significant renal or hepatic impairment
• Pregnancy or child-bearing potential

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 90 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Corthera, Inc.

Overall Clinical Trial Officials and Contacts

Sam Teichman, MD Study Director BAS Medical - Sponsor  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00259116

Study ID Number: RLX.CHF.001

ClinicalTrials.gov Identifier: NCT00259116

Health Authority: Germany: Federal Institute for Drugs and Medical Devices