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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
ClinicalTrials.gov Identifier:
NCT00520806
First received: August 24, 2007
Last updated: October 26, 2012
Last verified: May 2012

August 24, 2007
October 26, 2012
October 2007
September 2012   (final data collection date for primary outcome measure)
Relief of dyspnea in acute heart failure [ Time Frame: Up to day 5 ] [ Designated as safety issue: No ]
Signs and symptoms of acute heart failure
Complete list of historical versions of study NCT00520806 on ClinicalTrials.gov Archive Site
  • 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 ]
Renal function
Not Provided
Not Provided
 
Efficacy and Safety of Relaxin for the Treatment of Acute Heart Failure
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

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

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Heart Failure, Congestive
  • Drug: Relaxin
    Intravenous infusion for 48 h at 30 ug/kg/day
  • Drug: Placebo
    Intravenous infusion for 48 h
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1161
September 2012
September 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Israel
 
NCT00520806
RLX.CHF.003
Yes
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
Not Provided
Study Director: Thomas Severin, MD Novartis Pharmaceuticals
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
May 2012

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