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Completed

NCT Number: NCT00520806

Efficacy and Safety of Relaxin for the Treatment of 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

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Key information

Conditions

Heart Failure, Congestive Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Heart Failure Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Heart Institute, Safed, Israel

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

relaxin

Drug

Intravenous infusion for 48 h at 30 ug/kg/day

Placebo

Drug

Intravenous infusion for 48 h

Primary outcomes

  1. Relief of dyspnea in acute heart failure

    Time frame: Up to day 5

Secondary outcomes

  1. Days alive and out of hospital

    Time frame: Up to day 60

  2. CV death or rehospitalization due to heart failure or renal failure

    Time frame: Up to day 60

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study 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

Acronym: RELAX-AHF

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Aug 27, 2007
Registry last updated
Oct 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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