Hemodynamic Effects of Chronic Administration of Spironolactone and/or Propranolol in Alcoholic Cirrhotic Patients
Information source: University Hospital, Angers
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Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alcoholic Cirrhosis
Intervention: Propranolol - Spironolactone (Drug)
Phase: Phase 4
Sponsored by: University Hospital, Angers
Official(s) and/or principal investigator(s):
Paul Cales, PHD, Principal Investigator, Affiliation: UH Angers
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.
Official title: Hemodynamic Effects of Chronic Administration of Spironolactone, Propranolol and Their Association in Alcoholic Cirrhotic Patients
Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Primary outcome: assessment of hepatic veinous pressure gradient changes after chronic treatment by spironolactone or propranolol alone or in association.
Secondary outcome: Efficacy of spironolactone/propranolol association
Minimum age: 18 Years.
Maximum age: 75 Years.
- Indication of transjugular hepatic biopsy
- alcoholic cirrhosis
- presence of oesophageal varices ≤ stade 2
- 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
Locations and Contacts
Starting date: April 1995
Last updated: December 28, 2005