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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-04-30

Study Completion Date

2003-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alcoholic Cirrhosis

Keywords

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Portal hypertension, alcoholic cirrhosis, Hepatic venous pressure gradient, hemodynamic, spironolactone, propranolol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Propranolol - Spironolactone

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Paul Cales, PHD

Role: PRINCIPAL_INVESTIGATOR

UH Angers

Other Identifiers

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PHRC 01-13

Identifier Type: -

Identifier Source: org_study_id