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

Phase 3CompletedNCT00520806

Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies1,161 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

1,161

Conditions

Heart Failure, Congestive

Interventions

RelaxinDRUG

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

PlaceboDRUG

Intravenous infusion for 48 h

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Northwestern University

Chicago, Illinois, United States

Wayne State University/Detroit Receiving Hospital

Detroit, Michigan, United States

Heart Institute

Safed, Israel

Outcomes

Primary Outcomes

Relief of dyspnea in acute heart failure

Time frame: Up to day 5

Secondary Outcomes

Days alive and out of hospital

Time frame: Up to day 60

CV death or rehospitalization due to heart failure or renal failure

Time frame: Up to day 60

Data from ClinicalTrials.gov

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