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
  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 2
Phase 3

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:


Further study details as provided by Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies:

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 ]

Enrollment: 1161
Study Start Date: October 2007
Study Completion Date: September 2012
Primary Completion Date: September 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00520806

Locations
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
Study Director: Thomas Severin, MD Novartis Pharmaceuticals
  More Information

No publications provided by Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies

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

Responsible Party: Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
ClinicalTrials.gov Identifier: NCT00520806     History of Changes
Other Study ID Numbers: RLX.CHF.003
Study First Received: August 24, 2007
Last Updated: October 26, 2012
Health Authority: United States: Food and Drug Administration
Israel: Ministry of Health

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:
Heart Failure
Cardiovascular Diseases
Heart Diseases
Methocarbamol
Central Nervous System Agents
Muscle Relaxants, Central
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014