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

NCT ID: NCT00259116

Last Updated: 2009-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30

Brief Summary

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.

Detailed 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.

Conditions

Heart Failure, Congestive

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Relaxin

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies

INDUSTRY

Sponsor Role: lead

Responsible Party

BAS Medical

Principal Investigators

Sam Teichman, MD

Role: STUDY_DIRECTOR

BAS Medical - Sponsor

Locations

Charite Hospital

Berlin, , Germany

Countries

Germany

Other Identifiers

RLX.CHF.001

Identifier Type: -

Identifier Source: org_study_id