Recombinant Human Relaxin for the Treatment of Decompensated CHF

Congestive Heart Failure (CHF) Clinical Trial

Official title:

A Phase II Randomized, Double Blind, Placebo-Controlled Study of Recombinant Human Relaxin in Patients With Decompensated Congestive Heart Failure

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00406575
• Other study ID #: RLX.CHF.002
• Status: Terminated
• Phase: Phase 2
• First received: November 30, 2006
• Last updated: May 6, 2014
• Start date: November 2006
• Est. completion date: January 2007

Study information

• Verified date: May 2014
• 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 Administration
• Study type: Interventional

Clinical Trial Summary

Two doses of relaxin will be compared to placebo for the treatment of patients with decompensated CHF

Description:

Pilot clinical data suggest that recombinant human relaxin may be effective in treating patients with decompensated CHF. This study will randomize patients in blinded manner to one of two doses of intravenous relaxin or placebo. Serial evaluations will include cardiac and renal function, as well as safety and tolerability.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Hospitalization

• Decompensated chronic CHF (NYHA Class III-IV)

• LVEF < 35%

• PCWP > 22 mmHg

• CI < 2.3 L/min/m2

Exclusion Criteria:

• Acute CHF

• Acute coronary syndrome

• Hypotension or shock

• Recent stroke

• Allergy or sensitivity to test agents

• Significant confounding conditions or medications

Study Design

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

Related Conditions & MeSH terms

• Congestive Heart Failure (CHF)
• Heart Failure

Intervention

Drug:
• Placebo
Placebo was the diluent used for preparation of the 100 µg/kg/day dose of active study medication.
• Recombinant human relaxin (rhRlx)
Recombinant human relaxin (rhRlx) diluted for continuous IV infusion.

Locations

Country	Name	City	State
Russian Federation	Educational Scientific Medical Center of the General Management Department of the President of Russian Federation. City Clinical Hospital ?51	Moscow
Russian Federation	Russian Scientific Centre of Surgery n.a. B.V.Petrovsky of Russian Academy of Medical Sciences	Moscow

Sponsors (1)

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

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac hemodynamics		Baseline through 27 hours post-infusion or discharge from the hospital.	No
Secondary	Renal function	Renal function was to be assessed by evaluation of serum creatinine, creatinine clearance, BUN, uric acid, GFR, RBF, urine output, sodium clearance, and body weight.	Baseline through Day 10
Secondary	Safety and Tolerability assessed by number of patients with adverse events (AEs)		Baseline through Day 30	Yes