Efficacy and Safety of Relaxin for the Treatment of Acute Heart Failure - Full Text View

Efficacy and Safety of Relaxin for the Treatment of Acute Heart Failure (RELAX-AHF)

This study is currently recruiting participants.

Verified by Corthera, Inc., April 2009

First Received: August 24, 2007 Last Updated: April 13, 2009 History of Changes

Sponsor:	Corthera, Inc.
Information provided by:	Corthera, Inc.
ClinicalTrials.gov Identifier:	NCT00520806

Purpose

Different doses of relaxin will be compared to placebo to determine efficacy and safety for the treatment of patients hospitalized with acute heart failure

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase II/III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Relaxin in Subjects With Acute 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:

Signs and symptoms of acute heart failure

Secondary Outcome Measures:

Renal function

Study Start Date:

October 2007

Intervention Details:

intravenous infusion for 48 h

Detailed Description:

This is an international, randomized, double-blind, placebo-controlled trial of intravenous recombinant relaxin for the treatment of signs and symptoms in patients hospitalized for acute decompensated heart failure. A pilot study will determine the optimum dose of relaxin which will be studied further in the main portion of the trial.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Hospitalized for acute heart failure
Dyspnea at rest or with minimal exertion
Pulmonary congestion
Able to provide informed consent

Exclusion Criteria:

Use of other IV therapies for acute heart failure
Fever or sepsis
Recent major neurologic event
Recent major surgery
Recent acute coronary syndrome
Other recent investigational drug use

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00520806

Contacts

Contact: Sam Teichman, MD

925.314.0569

Locations

United States, Illinois
Northwestern University	Recruiting
Chicago, Illinois, United States, 60611
Contact: Peter Pang
United States, Michigan
Wayne State University/Detroit Receiving Hospital	Recruiting
Detroit, Michigan, United States, 48201
Contact: Phillip Levy
United States, Ohio
University of Cincinnati College of Medicine	Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Sean Collins
Israel
Heart Institute	Recruiting
Safed, Israel

Sponsors and Collaborators

Corthera, Inc.

Investigators

Study Director:

Sam Teichman, MD

Corthera, Inc.

More Information

No publications provided by Corthera, Inc.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Teerlink JR, Metra M, Felker GM, Ponikowski P, Voors AA, Weatherley BD, Marmor A, Katz A, Grzybowski J, Unemori E, Teichman SL, Cotter G. Relaxin for the treatment of patients with acute heart failure (Pre-RELAX-AHF): a multicentre, randomised, placebo-controlled, parallel-group, dose-finding phase IIb study. Lancet. 2009 Apr 25;373(9673):1429-39. Epub 2009 Mar 28.

Responsible Party:	Corthera, Inc. ( Sam Teichman, Chief Medical Officer )
Study ID Numbers:	RLX.CHF.003
Study First Received:	August 24, 2007
Last Updated:	April 13, 2009
ClinicalTrials.gov Identifier:	NCT00520806 History of Changes
Health Authority:	United States: Food and Drug Administration; Israel: Ministry of Health

Keywords provided by Corthera, Inc.:

Heart failure
Renal dysfunction
Relaxin
Vasodilator

Additional relevant MeSH terms:

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

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

ClinicalTrials.gov processed this record on November 25, 2009