Hemodynamic Effects of Chronic Administration of Spironolactone and/or Propranolol in Alcoholic Cirrhotic Patients
Information source: University Hospital, Angers
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alcoholic Cirrhosis
Intervention: Propranolol - Spironolactone (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: University Hospital, Angers Official(s) and/or principal investigator(s):
Paul Cales, PHD, Principal Investigator, Affiliation: UH Angers
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.
Clinical Details
Official title: Hemodynamic Effects of Chronic Administration of Spironolactone, Propranolol and Their Association in Alcoholic Cirrhotic Patients
Study design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Pharmacodynamics Study
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
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: April 1995
Ending date: December 2003
Last updated: December 28, 2005
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