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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00520806
Other study ID # RLX.CHF.003
Secondary ID
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


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
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