A Pilot Study of 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...
Brief Summary
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: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Intervention(s) in this Clinical Trial
- Drug: Relaxin
Outcome Measures for this Clinical Trial
Primary Measures
- Cardiac hemodynamics including PCWP, CO/CI, SVR
- Safety Issue?: No
Secondary Measures
- Safety and tolerability
- Safety Issue?: Yes
- 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
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
Clinical Trial Investigator Information
Lead Investigator: Corthera, Inc. Industry
Overall Clinical Trial Officials and Contacts
Sam Teichman, MD Study Director BAS Medical - Sponsor
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
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
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00259116
