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Clinical Trials/NCT00188045
NCT00188045TerminatedPhase 4

Hemodynamic Effects of Chronic Administration of Spironolactone, Propranolol and Their Association in Alcoholic Cirrhotic Patients

University Hospital, Angers0 sites54 target enrollmentStarted: April 1, 1995Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Terminated
Sponsor
Enrollment
54
Primary Endpoint
assessment of hepatic veinous pressure gradient changes after chronic treatment by spironolactone or propranolol alone or in association.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The aim of this study was assesment of splanchnic and systemic hemodynamic effects of chronic administration (2 month) of spironolactone or propranolol, alone or in association in alcoholic cirrhotic patients. The patients were randomized in 4 groups (aldactone 150 mg/day, propranolol 160 mg/day, aldactone 150 mg/day + propranolol 160 mg/day, placebo). Systemic and splanchnic hemodynamic effect were evaluated by hepatic venous pressure gradient measurements before and after 2 month of treatment.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Double

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Indication of transjugular hepatic biopsy
  • •alcoholic cirrhosis
  • •presence of oesophageal varices ≤ stade 2

Exclusion Criteria

  • •renal insufficiency
  • •natremia ≤ 135 mmol/l
  • •vasoactive treatment in the last month before inclusion
  • •hepatocellular carcinoma
  • •positive HIV and HCV patients
  • •paracentesis in the last week before inclusion
  • •digestive bleeding in one last week
  • •oesophageal varices stade 3 or 2 with red signs

Outcomes

Primary Outcomes

assessment of hepatic veinous pressure gradient changes after chronic treatment by spironolactone or propranolol alone or in association.

Secondary Outcomes

  • Efficacy of spironolactone/propranolol association

Investigators

Sponsor
University Hospital, Angers
Sponsor Class
Other Gov

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