Recombinant Human Relaxin for the Treatment of Decompensated CHF

This study has been completed.
Sponsor:
Information provided by:
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
ClinicalTrials.gov Identifier:
NCT00406575
First received: November 30, 2006
Last updated: April 13, 2009
Last verified: April 2009
  Purpose

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


Condition Intervention Phase
Congestive Heart Failure (CHF)
Drug: Recombinant human relaxin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase II Randomized, Double Blind, Placebo-Controlled Study of Recombinant Human Relaxin in Patients With Decompensated Congestive Heart Failure

Resource links provided by NLM:


Further study details as provided by Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies:

Primary Outcome Measures:
  • Cardiac hemodynamics

Secondary Outcome Measures:
  • Renal function
  • Safety
  • Tolerability

Study Start Date: November 2006
Detailed 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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00406575

Locations
Russian Federation
Russian Scientific Centre of Surgery n.a. B.V.Petrovsky of Russian Academy of Medical Sciences
Moscow, Russian Federation, 119992
Educational Scientific Medical Center of the General Management Department of the President of Russian Federation. City Clinical Hospital №51
Moscow, Russian Federation, 121309
Sponsors and Collaborators
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
Investigators
Principal Investigator: Thomas Dschietzig, MD Charite Hospital, Berlin, Germany
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00406575     History of Changes
Other Study ID Numbers: RLX.CHF.002
Study First Received: November 30, 2006
Last Updated: April 13, 2009
Health Authority: Russia: Ministry of Health

Keywords provided by Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies:
Congestive heart failure
Relaxin
Hemodynamics
Renal function

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Methocarbamol
Muscle Relaxants, Central
Physiological Effects of Drugs
Pharmacologic Actions
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014