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

University Hospital, Angers

Status and phase: Terminated; Phase 4

Conditions: Alcoholic Cirrhosis

Treatments: Drug: Propranolol - Spironolactone

Study type: Interventional

Funder types: Other

Identifiers

NCT00188045

PHRC 01-13

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind