Efficacy and Safety of Relaxin for the Treatment of Acute Heart Failure

Heart Failure, Congestive Clinical Trial

— RELAX-AHF  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00520806
• Other study ID #: RLX.CHF.003
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 24, 2007
• Last updated: October 26, 2012
• Start date: October 2007
• Est. completion date: September 2012

Study information

• Verified date: May 2012
• Source: Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIsrael: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1161
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Congestive

Intervention

Drug:
• Relaxin
Intravenous infusion for 48 h at 30 ug/kg/day
• Placebo
Intravenous infusion for 48 h

Locations

Country	Name	City	State
Israel	Heart Institute	Safed
United States	Northwestern University	Chicago	Illinois
United States	Wayne State University/Detroit Receiving Hospital	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relief of dyspnea in acute heart failure		Up to day 5	No
Secondary	Days alive and out of hospital		Up to day 60	No
Secondary	CV death or rehospitalization due to heart failure or renal failure		Up to day 60	No