Hemodynamic Effects of Chronic Administration of Spironolactone and/or Propranolol in Alcoholic Cirrhotic Patients

Phase 4TerminatedNCT00188045

University Hospital, Angers54 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Alcoholic Cirrhosis

Interventions

Propranolol - SpironolactoneDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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