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...
Date First Received: November 28, 2005
Last Updated: April 21, 2008
Verified by: BAS Medical, April 2008
Clinical Trial Phase: Phase 2 | Start Date: November 2005
Overall Status: Completed
Estimated Enrollment: 18
Brief Summary
Official Title: “A Pilot Safety and Dose-Finding Trial of Intravenous Recombinant Human Relaxin (rhRlx) in Compensated Congestive Heart Failure”
Condition Keyword(s):
Intervention(s):
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
Detailed Clinical Trial Description
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.
Outcome Measures for this Clinical Trial
Primary:
- Cardiac hemodynamics
Secondary:
- Safety
- Tolerability
Criteria for Participation in this Clinical Trial
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
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: BAS Medical
Charite Hospital
Berlin 10117 Germany
Overall Clinical Trial Officials and Contacts
Sam Teichman, MD Study Director BAS Medical - Sponsor
Additional Information
Information obtained from ClinicalTrials.gov on July 18, 2008
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
Clinical Trials Authorship and Review
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