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NCT00259116 Clinical Trial

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

Heart Failure, Congestive Clinical Trial

Official title:
A Pilot Safety and Dose-Finding Trial of Intravenous Recombinant Human Relaxin (rhRlx) in Compensated Congestive Heart Failure

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00259116
Other study ID # RLX.CHF.001
Secondary ID
Status Completed
Phase Phase 2
First received November 28, 2005
Last updated April 13, 2009
Start date November 2005

Study information
Verified date April 2009
Source Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Relaxin

Locations
Country Name City State
Germany Charite Hospital Berlin

Sponsors (1)
Lead Sponsor Collaborator
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cardiac hemodynamics including PCWP, CO/CI, SVR No
Secondary Safety and tolerability Yes
Secondary Tolerability
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