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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

Tracking Information
First Submitted Date  ICMJE August 24, 2007
First Posted Date  ICMJE August 27, 2007
Last Update Posted Date October 30, 2012
Study Start Date  ICMJE October 2007
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2011)		 Relief of dyspnea in acute heart failure [ Time Frame: Up to day 5 ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 24, 2007)		 Signs and symptoms of acute heart failure
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2011)
  • Days alive and out of hospital [ Time Frame: Up to day 60 ]
  • CV death or rehospitalization due to heart failure or renal failure [ Time Frame: Up to day 60 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2007)		 Renal function
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Relaxin for the Treatment of Acute Heart Failure
Official Title  ICMJE 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
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure, Congestive
Intervention  ICMJE
  • Drug: Relaxin
    Intravenous infusion for 48 h at 30 ug/kg/day
  • Drug: Placebo
    Intravenous infusion for 48 h
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    48 hour iv infusion of placebo
    Intervention: Drug: Placebo
  • Experimental: Relaxin
    48 hour iv infusion of relaxin at 30 ug/kg/day
    Intervention: Drug: Relaxin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 26, 2012)		 1161
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel,   United States
Removed Location Countries Russian Federation
 
Administrative Information
NCT Number  ICMJE NCT00520806
Other Study ID Numbers  ICMJE RLX.CHF.003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Thomas Severin, MD Novartis Pharmaceuticals
PRS Account Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP