Hemodynamic Effects of Chronic Administration of Spironolactone and/or Propranolol in Alcoholic Cirrhotic Patients
Primary Purpose
Alcoholic Cirrhosis
Status
Terminated
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Propranolol - Spironolactone
Sponsored by
About this trial
This is an interventional prevention trial for Alcoholic Cirrhosis focused on measuring Portal hypertension, alcoholic cirrhosis, Hepatic venous pressure gradient, hemodynamic, spironolactone, propranolol
Eligibility 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
Sites / Locations
Outcomes
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
Full Information
NCT ID
NCT00188045
First Posted
September 12, 2005
Last Updated
October 30, 2017
Sponsor
University Hospital, Angers
1. Study Identification
Unique Protocol Identification Number
NCT00188045
Brief Title
Hemodynamic Effects of Chronic Administration of Spironolactone and/or Propranolol in Alcoholic Cirrhotic Patients
Official Title
Hemodynamic Effects of Chronic Administration of Spironolactone, Propranolol and Their Association in Alcoholic Cirrhotic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2001
Overall Recruitment Status
Terminated
Study Start Date
April 1995 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2003 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Angers
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholic Cirrhosis
Keywords
Portal hypertension, alcoholic cirrhosis, Hepatic venous pressure gradient, hemodynamic, spironolactone, propranolol
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
54 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Propranolol - Spironolactone
Primary Outcome Measure Information:
Title
assessment of hepatic veinous pressure gradient changes after chronic treatment by spironolactone or propranolol alone or in association.
Secondary Outcome Measure Information:
Title
Efficacy of spironolactone/propranolol association
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Cales, PHD
Organizational Affiliation
UH Angers
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Hemodynamic Effects of Chronic Administration of Spironolactone and/or Propranolol in Alcoholic Cirrhotic Patients
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