Recombinant Human Relaxin for the Treatment of Decompensated CHF

A Phase II Randomized, Double Blind, Placebo-Controlled Study of Recombinant Human Relaxin in Patients With Decompensated Congestive Heart Failure

Two doses of relaxin will be compared to placebo for the treatment of patients with decompensated CHF

Pilot clinical data suggest that recombinant human relaxin may be effective in treating patients with decompensated CHF. This study will randomize patients in blinded manner to one of two doses of intravenous relaxin or placebo. Serial evaluations will include cardiac and renal function, as well as safety and tolerability.

Inclusion Criteria:

• Hospitalization
• Decompensated chronic CHF (NYHA Class III-IV)
• LVEF < 35%
• PCWP > 22 mmHg
• CI < 2.3 L/min/m2

Exclusion Criteria:

• Acute CHF
• Acute coronary syndrome
• Hypotension or shock
• Recent stroke
• Allergy or sensitivity to test agents
• Significant confounding conditions or medications