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

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

December 28, 2005

Start Date ^ICMJE

April 1995

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00188045 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Efficacy of spironolactone/propranolol association

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Pharmacodynamics Study

Condition ^ICMJE

Alcoholic Cirrhosis

Intervention ^ICMJE

Drug: Propranolol - Spironolactone

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

December 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00188045

Responsible Party

Study ID Numbers ^ICMJE

PHRC 01-13

Study Sponsor ^ICMJE

University Hospital, Angers

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Paul Cales, PHD

UH Angers

Information Provided By

University Hospital, Angers

Verification Date

December 2001

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP