A Pilot Study of Recombinant Human Relaxin (rhRlx) in Compensated Congestive Heart Failure - Full Text View

Sponsored by:	BAS Medical
Information provided by:	BAS Medical
ClinicalTrials.gov Identifier:	NCT00259116

Purpose

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.

Condition	Intervention	Phase
Heart Failure, Congestive	Drug: Relaxin	Phase II

MedlinePlus related topics: Heart Failure

Drug Information available for: Relaxin Methocarbamol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Pilot Safety and Dose-Finding Trial of Intravenous Recombinant Human Relaxin (rhRlx) in Compensated Congestive Heart Failure

Further study details as provided by BAS Medical:

Primary Outcome Measures:

Cardiac hemodynamics

Secondary Outcome Measures:

Safety
Tolerability

Estimated Enrollment:	18
Study Start Date:	November 2005

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.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00259116

Locations

Germany
Charite Hospital
Berlin, Germany, 10117

Sponsors and Collaborators

BAS Medical

Investigators

Study Director:

Sam Teichman, MD

BAS Medical - Sponsor

More Information

Responsible Party:	BAS Medical ( Sam teichman, Chief Medical Officer )
Study ID Numbers:	RLX.CHF.001
Study First Received:	November 28, 2005
Last Updated:	April 21, 2008
ClinicalTrials.gov Identifier:	NCT00259116
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by BAS Medical:

Congestive heart failure
Relaxin
Cardiac hemodynamics

Study placed in the following topic categories:

Signs and Symptoms
Heart Failure
Heart Diseases
Methocarbamol

Additional relevant MeSH terms:

Therapeutic Uses
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents

Cardiovascular Diseases
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009