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

This study has been completed.

First Received on November 28, 2005. Last Updated on April 13, 2009 History of Changes

Sponsor:	Corthera, Inc.
Information provided by:	Corthera, Inc.
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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Pilot Safety and Dose-Finding Trial of Intravenous Recombinant Human Relaxin (rhRlx) in Compensated Congestive Heart Failure

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

Drug Information available for: Methocarbamol Relaxin

U.S. FDA Resources

Further study details as provided by Corthera, Inc.:

Primary Outcome Measures:

Cardiac hemodynamics including PCWP, CO/CI, SVR [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability [ Designated as safety issue: Yes ]
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

Corthera, Inc.

Investigators

Study Director:

Sam Teichman, MD

BAS Medical - Sponsor

More Information

No publications provided

Responsible Party:	Sam Teichman, Chief Medical Officer, BAS Medical
ClinicalTrials.gov Identifier:	NCT00259116 History of Changes
Other Study ID Numbers:	RLX.CHF.001
Study First Received:	November 28, 2005
Last Updated:	April 13, 2009
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Corthera, Inc.:

Congestive heart failure
Relaxin
Cardiac hemodynamics

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases
Methocarbamol
Muscle Relaxants, Central
Physiological Effects of Drugs

Pharmacologic Actions
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012