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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

Page last updated: June 20, 2008

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