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

This study has been terminated.

First Received on September 12, 2005. Last Updated on December 28, 2005 History of Changes

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention
Official Title:	Hemodynamic Effects of Chronic Administration of Spironolactone, Propranolol and Their Association in Alcoholic Cirrhotic Patients

Resource links provided by NLM:

Genetics Home Reference related topics: North American Indian childhood cirrhosis

MedlinePlus related topics: Cirrhosis High Blood Pressure

Drug Information available for: Spironolactone Propranolol hydrochloride Propranolol Dexpropranolol

U.S. FDA Resources

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

No publications provided

ClinicalTrials.gov Identifier:	NCT00188045 History of Changes
Other Study ID Numbers:	PHRC 01-13
Study First Received:	September 12, 2005
Last Updated:	December 28, 2005
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

Additional relevant MeSH terms:

Liver Cirrhosis
Fibrosis
Liver Cirrhosis, Alcoholic
Liver Diseases
Digestive System Diseases
Pathologic Processes
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Propranolol
Spironolactone
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses

Pharmacologic Actions
Antihypertensive Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vasodilator Agents
Aldosterone Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Diuretics
Natriuretic Agents

ClinicalTrials.gov processed this record on February 09, 2012