Recombinant Human Relaxin for the Treatment of Decompensated CHF

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
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: May 6, 2014
Last verified: May 2014
  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: Placebo
Drug: Recombinant human relaxin (rhRlx)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
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 [ Time Frame: Baseline through 27 hours post-infusion or discharge from the hospital. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Renal function [ Time Frame: Baseline through Day 10 ]
    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.

  • Safety and Tolerability assessed by number of patients with adverse events (AEs) [ Time Frame: Baseline through Day 30 ] [ Designated as safety issue: Yes ]

Enrollment: 11
Study Start Date: November 2006
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Participants receive diluent via continuous IV infusion for 48 hours.
Drug: Placebo
Placebo was the diluent used for preparation of the 100 µg/kg/day dose of active study medication.
Other Name: Diluent
Experimental: Low Dose rhRlx
Participants receive recombinant human relaxin (rhRlx) via continuous IV infusion for 48 hours at a rate of 100 µg/kg/day (corresponding to a dose of 4.2 µg/kg/hr).
Drug: Recombinant human relaxin (rhRlx)
Recombinant human relaxin (rhRlx) diluted for continuous IV infusion.
Other Names:
  • serelaxin
  • serelaxin (RLX030)
Experimental: High Dose rhRlx
Participants receive recombinant human relaxin (rhRlx) via continuous IV infusion for 48 hours at a rate of 500 µg/kg/day (corresponding to a dose of 21.0 µg/kg/hr).
Drug: Recombinant human relaxin (rhRlx)
Recombinant human relaxin (rhRlx) diluted for continuous IV infusion.
Other Names:
  • serelaxin
  • serelaxin (RLX030)

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Russian Federation
Educational Scientific Medical Center of the General Management Department of the President of Russian Federation. City Clinical Hospital №51
Moscow, Russian Federation, 121309
Russian Scientific Centre of Surgery n.a. B.V.Petrovsky of Russian Academy of Medical Sciences
Moscow, Russian Federation, 119992
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

Responsible Party: Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies
ClinicalTrials.gov Identifier: NCT00406575     History of Changes
Other Study ID Numbers: RLX.CHF.002
Study First Received: November 30, 2006
Last Updated: May 6, 2014
Health Authority: United States: Food and Drug Administration

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
Cardiovascular Diseases
Heart Diseases
Methocarbamol
Central Nervous System Agents
Muscle Relaxants, Central
Neuromuscular Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014