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

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

Study Overview

Status

Completed

Intervention / Treatment

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

Interventional

Enrollment (Actual)

1161

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Safed, Israel
        • Heart Institute
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University/Detroit Receiving Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
48 hour iv infusion of placebo
Intravenous infusion for 48 h
Experimental: Relaxin
48 hour iv infusion of relaxin at 30 ug/kg/day
Intravenous infusion for 48 h at 30 ug/kg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Relief of dyspnea in acute heart failure
Time Frame: Up to day 5
Up to day 5

Secondary Outcome Measures

Outcome Measure
Time Frame
Days alive and out of hospital
Time Frame: Up to day 60
Up to day 60
CV death or rehospitalization due to heart failure or renal failure
Time Frame: Up to day 60
Up to day 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Thomas Severin, MD, Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

August 24, 2007

First Submitted That Met QC Criteria

August 24, 2007

First Posted (Estimate)

August 27, 2007

Study Record Updates

Last Update Posted (Estimate)

October 30, 2012

Last Update Submitted That Met QC Criteria

October 26, 2012

Last Verified

May 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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