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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Safety and Dose-Finding Trial of Intravenous Recombinant Human Relaxin (rhRlx) in Compensated Congestive Heart Failure|
- Cardiac hemodynamics including PCWP, CO/CI, SVR [ Designated as safety issue: No ]
- Safety and tolerability [ Designated as safety issue: Yes ]
|Study Start Date:||November 2005|
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.