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

Corthera

Status and phase: Completed; Phase 2

Conditions: Heart Failure, Congestive

Treatments: Drug: Relaxin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00259116

RLX.CHF.001

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)