Status:

TERMINATED

Recombinant Human Relaxin for the Treatment of Decompensated CHF

Lead Sponsor:

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

Conditions:

Congestive Heart Failure (CHF)

Eligibility:

All Genders

19+ years

Phase:

PHASE2

Brief Summary

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

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 int...

Eligibility Criteria

Inclusion

  • Hospitalization
  • Decompensated chronic CHF (NYHA Class III-IV)
  • LVEF \< 35%
  • PCWP \> 22 mmHg
  • CI \< 2.3 L/min/m2

Exclusion

  • Acute CHF
  • Acute coronary syndrome
  • Hypotension or shock
  • Recent stroke
  • Allergy or sensitivity to test agents
  • Significant confounding conditions or medications

Key Trial Info

Start Date :

November 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2007

Estimated Enrollment :

11 Patients enrolled

Trial Details

Trial ID

NCT00406575

Start Date

November 1 2006

End Date

January 1 2007

Last Update

May 7 2014

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Russian Scientific Centre of Surgery n.a. B.V.Petrovsky of Russian Academy of Medical Sciences

Moscow, Russia, 119992

2

Educational Scientific Medical Center of the General Management Department of the President of Russian Federation. City Clinical Hospital №51

Moscow, Russia, 121309