Recombinant Human Relaxin for the Treatment of Decompensated CHF

Condition(s) targeted: Congestive Heart Failure (CHF)

Intervention: Recombinant human relaxin (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: BAS Medical

Official(s) and/or principal investigator(s):
Thomas Dschietzig, MD, Principal Investigator, Affiliation: Charite Hospital, Berlin, Germany

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

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

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Cardiac hemodynamics

Secondary outcome:

Renal function

Safety

Tolerability

Detailed description: 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.

Minimum age: 19 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Russian Scientific Centre of Surgery n.a. B.V.Petrovsky of Russian Academy of Medical Sciences, Moscow 119992, Russian Federation

Educational Scientific Medical Center of the General Management Department of the President of Russian Federation. City Clinical Hospital №51, Moscow 121309, Russian Federation

Starting date: November 2006
Last updated: August 3, 2007