A Pilot Study of Recombinant Human Relaxin (rhRlx) in Compensated Congestive Heart Failure

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.

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.

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