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

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 Drug: Placebo	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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:

Relief of dyspnea in acute heart failure [ Time Frame: Up to day 5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Days alive and out of hospital [ Time Frame: Up to day 60 ] [ Designated as safety issue: No ]
CV death or rehospitalization due to heart failure or renal failure [ Time Frame: Up to day 60 ] [ Designated as safety issue: No ]

Estimated Enrollment:	1160
Study Start Date:	October 2007
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo 48 hour iv infusion of placebo	Drug: Placebo Intravenous infusion for 48 h
Experimental: Relaxin 48 hour iv infusion of relaxin at 30 ug/kg/day	Drug: Relaxin Intravenous infusion for 48 h at 30 ug/kg/day

Detailed Description:

This is an international, randomized, double-blind, placebo-controlled, Phase II/III trial of intravenous recombinant relaxin for the treatment of signs and symptoms in patients hospitalized for acute decompensated heart failure. The Phase II pilot study has completed; the Phase III main portion of the trial is ongoing.

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
Systolic blood pressure > 125 mmHg
Impaired renal function defined as an eGFR of 30-75 mL/min/1.73m2

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: Elaine Unemori, PhD

650.235.3568

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
Israel
Heart Institute	Recruiting
Safed, Israel

Sponsors and Collaborators

Corthera, Inc.

Investigators

Study Director:

Thomas Severin, MD

Novartis Pharmaceuticals

More Information

No publications provided by Corthera, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Voors AA, Davison BA, Felker GM, Ponikowski P, Unemori E, Cotter G, Teerlink JR, Greenberg BH, Filippatos G, Teichman SL, Metra M; Pre-RELAX-AHF study group. Early drop in systolic blood pressure and worsening renal function in acute heart failure: renal results of Pre-RELAX-AHF. Eur J Heart Fail. 2011 Sep;13(9):961-7. Epub 2011 May 28.

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:	Thomas Severin, Global Program Medical Director, Novartis Pharma, AG
ClinicalTrials.gov Identifier:	NCT00520806 History of Changes
Other Study ID Numbers:	RLX.CHF.003
Study First Received:	August 24, 2007
Last Updated:	July 15, 2011
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
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 13, 2012