Status:
COMPLETED
A Pilot Study of Recombinant Human Relaxin (rhRlx) in Compensated Congestive Heart Failure
Lead Sponsor:
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
Conditions:
Heart Failure, Congestive
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief 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.
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 ...
Eligibility Criteria
Inclusion
- 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
- Acute coronary syndrome
- Acute decompensated CHF
- Hypotension
- Recent significant arrhythmia
- Recent stroke
- Significant renal or hepatic impairment
- Pregnancy or child-bearing potential
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00259116
Start Date
November 1 2005
Last Update
April 15 2009
Active Locations (1)
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1
Charite Hospital
Berlin, Germany, 10117