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Recombinant Human Relaxin for the Treatment of Decompensated CHF
This study has been completed.
Study NCT00406575   Information provided by Corthera, Inc.
First Received: November 30, 2006   Last Updated: April 13, 2009   History of Changes

November 30, 2006
April 13, 2009
November 2006
 
Cardiac hemodynamics
Same as current
Complete list of historical versions of study NCT00406575 on ClinicalTrials.gov Archive Site
  • Renal function
  • Safety
  • Tolerability
Same as current
 
Recombinant Human Relaxin for the Treatment of Decompensated CHF
A Phase II Randomized, Double Blind, Placebo-Controlled Study of Recombinant Human Relaxin in Patients With Decompensated Congestive Heart Failure

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

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.

Phase II
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Congestive Heart Failure (CHF)
Drug: Recombinant human relaxin
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT00406575
 
RLX.CHF.002
Corthera, Inc.
 
Principal Investigator: Thomas Dschietzig, MD Charite Hospital, Berlin, Germany
Corthera, Inc.
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP