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

This study has been terminated.

First Received: September 12, 2005 Last Updated: 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:	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

Resource links provided by NLM:

MedlinePlus related topics: Cirrhosis

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

Study ID Numbers:	PHRC 01-13
Study First Received:	September 12, 2005
Last Updated:	December 28, 2005
ClinicalTrials.gov Identifier:	NCT00188045 History of Changes
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 Diseases
Neurotransmitter Agents
Vasodilator Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Fibrosis
Hormone Antagonists
Diuretics
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Disorders of Environmental Origin
Liver Cirrhosis
Pathologic Processes
Propranolol
Therapeutic Uses

Substance-Related Disorders
Adrenergic beta-Antagonists
Alcohol-Related Disorders
Anti-Arrhythmia Agents
Alcohol-Induced Disorders
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Spironolactone
Liver Diseases, Alcoholic
Digestive System Diseases
Aldosterone Antagonists
Natriuretic Agents
Adrenergic Antagonists
Liver Cirrhosis, Alcoholic

ClinicalTrials.gov processed this record on November 27, 2009