A Pilot Study of Recombinant Human Relaxin (rhRlx) in Compensated Congestive Heart Failure
Phase 2
Completed
- Conditions
- Heart Failure, Congestive
- Registration Number
- NCT00259116
- Lead Sponsor
- Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
- 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 hemodynamics will be assessed.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Cardiac hemodynamics including PCWP, CO/CI, SVR
- Secondary Outcome Measures
Name Time Method Safety and tolerability Tolerability
Trial Locations
- Locations (1)
Charite Hospital
🇩🇪Berlin, Germany
Charite Hospital🇩🇪Berlin, Germany