Recombinant Human Relaxin for the Treatment of Decompensated CHF

This study has been completed.

First Received: November 30, 2006 Last Updated: April 13, 2009 History of Changes

Sponsor:	Corthera, Inc.
Information provided by:	Corthera, Inc.
ClinicalTrials.gov Identifier:	NCT00406575

Purpose

Two doses of relaxin will be compared to placebo for the treatment of patients with decompensated CHF

Condition	Intervention	Phase
Congestive Heart Failure (CHF)	Drug: Recombinant human relaxin	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase II Randomized, Double Blind, Placebo-Controlled Study of Recombinant Human Relaxin in Patients With Decompensated 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

Secondary Outcome Measures:

Renal function
Safety
Tolerability

Study Start Date:

November 2006

Detailed Description:

Pilot clinical data suggest that recombinant human relaxin may be effective in treating patients with decompensated CHF. This study will randomize patients in blinded manner to one of two doses of intravenous relaxin or placebo. Serial evaluations will include cardiac and renal function, as well as safety and tolerability.

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Hospitalization
Decompensated chronic CHF (NYHA Class III-IV)
LVEF < 35%
PCWP > 22 mmHg
CI < 2.3 L/min/m2

Exclusion Criteria:

Acute CHF
Acute coronary syndrome
Hypotension or shock
Recent stroke
Allergy or sensitivity to test agents
Significant confounding conditions or medications

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00406575

Locations

Russian Federation
Russian Scientific Centre of Surgery n.a. B.V.Petrovsky of Russian Academy of Medical Sciences
Moscow, Russian Federation, 119992
Educational Scientific Medical Center of the General Management Department of the President of Russian Federation. City Clinical Hospital №51
Moscow, Russian Federation, 121309

Sponsors and Collaborators

Corthera, Inc.

Investigators

Principal Investigator:

Thomas Dschietzig, MD

Charite Hospital, Berlin, Germany

More Information

No publications provided

Study ID Numbers:	RLX.CHF.002
Study First Received:	November 30, 2006
Last Updated:	April 13, 2009
ClinicalTrials.gov Identifier:	NCT00406575 History of Changes
Health Authority:	Russia: Ministry of Health

Keywords provided by Corthera, Inc.:

Congestive heart failure
Relaxin
Hemodynamics
Renal function

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 27, 2009