A Pilot Study of Recombinant Human Relaxin (rhRlx) in Compensated Congestive Heart Failure
Information source: BAS Medical
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heart Failure, Congestive
Intervention: Relaxin (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: BAS Medical Official(s) and/or principal investigator(s):
Sam Teichman, MD, Study Director, Affiliation: BAS Medical - Sponsor
Summary
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.
Clinical Details
Official title: A Pilot Safety and Dose-Finding Trial of Intravenous Recombinant Human Relaxin (rhRlx) in Compensated Congestive Heart Failure
Study design: Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Cardiac hemodynamics
Secondary outcome: SafetyTolerability
Detailed 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Charite Hospital, Berlin 10117, Germany
Additional Information
Starting date: November 2005
Last updated: April 21, 2008
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