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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
University Hospital, Angers
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 12, 2005
    Last Updated
    October 30, 2017
    Sponsor
    University Hospital, Angers
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    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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