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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00520806
Recruitment Status : Completed
First Posted : August 27, 2007
Last Update Posted : October 30, 2012
Sponsor:
Information provided by (Responsible Party):
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Heart Failure, Congestive Drug: Relaxin Drug: Placebo Phase 2 Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1161 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2007
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Relief of dyspnea in acute heart failure [ Time Frame: Up to day 5 ]

Secondary Outcome Measures :
  1. Days alive and out of hospital [ Time Frame: Up to day 60 ]
  2. CV death or rehospitalization due to heart failure or renal failure [ Time Frame: Up to day 60 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00520806


Locations
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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Michigan
Wayne State University/Detroit Receiving Hospital
Detroit, Michigan, United States, 48201
Israel
Heart Institute
Safed, Israel
Sponsors and Collaborators
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
Investigators
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Study Director: Thomas Severin, MD Novartis Pharmaceuticals
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
ClinicalTrials.gov Identifier: NCT00520806    
Other Study ID Numbers: RLX.CHF.003
First Posted: August 27, 2007    Key Record Dates
Last Update Posted: October 30, 2012
Last Verified: May 2012
Keywords provided by Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies:
Heart failure
Renal dysfunction
Relaxin
Vasodilator
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Methocarbamol
 Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents