Hemodynamic Effects of Chronic Administration of Spironolactone and/or Propranolol in Alcoholic Cirrhotic Patients - Full Text View

Purpose

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.

Condition	Intervention	Phase
Alcoholic Cirrhosis	Drug: Propranolol - Spironolactone	Phase IV

MedlinePlus related topics:

Cirrhosis

Drug Information available for:

Propranolol Dexpropranolol Propranolol hydrochloride Spironolactone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Pharmacodynamics Study

Official Title:	Hemodynamic Effects of Chronic Administration of Spironolactone, Propranolol and Their Association in Alcoholic Cirrhotic Patients

Further study details as provided by University Hospital, Angers:

Primary Outcome Measures:

assessment of hepatic veinous pressure gradient changes after chronic treatment by spironolactone or propranolol alone or in association.

Secondary Outcome Measures:

Efficacy of spironolactone/propranolol association

Estimated Enrollment:	54
Study Start Date:	April 1995
Estimated Study Completion Date:	December 2003

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00188045

Sponsors and Collaborators

University Hospital, Angers

Investigators


Principal Investigator:	Paul Cales, PHD	UH Angers

More Information

Study ID Numbers:	PHRC 01-13
First Received:	September 12, 2005
Last Updated:	December 28, 2005
ClinicalTrials.gov Identifier:	NCT00188045
Health Authority:	France : Direction Générale de la santé - French General Health Administration

Keywords provided by University Hospital, Angers:

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

Study placed in the following topic categories:

Alcohol-Induced Disorders

Liver Diseases

Fibrosis

Disorders of Environmental Origin

Liver Cirrhosis

Hypertension, Portal

Portal hypertension

Spironolactone

Liver Diseases, Alcoholic

Digestive System Diseases

Propranolol

Substance-Related Disorders

Alcohol-Related Disorders

Liver Cirrhosis, Alcoholic

Hypertension

Additional relevant MeSH terms:

Neurotransmitter Agents

Vasodilator Agents

Adrenergic Agents

Molecular Mechanisms of Pharmacological Action

Hormone Antagonists

Diuretics

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Cardiovascular Agents

Antihypertensive Agents

Pharmacologic Actions

Pathologic Processes

Aldosterone Antagonists

Natriuretic Agents

Therapeutic Uses

Adrenergic beta-Antagonists

Adrenergic Antagonists

Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on November 30, 2008

Sponsored by:	University Hospital, Angers
Information provided by:	University Hospital, Angers
ClinicalTrials.gov Identifier:	NCT00188045