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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00188045
Recruitment Status : Terminated
First Posted : September 16, 2005
Last Update Posted : November 1, 2017
Sponsor:
Information provided by:
University Hospital, Angers

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alcoholic Cirrhosis Drug: Propranolol - Spironolactone Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Hemodynamic Effects of Chronic Administration of Spironolactone, Propranolol and Their Association in Alcoholic Cirrhotic Patients
Study Start Date : April 1995
Study Completion Date : December 2003

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. assessment of hepatic veinous pressure gradient changes after chronic treatment by spironolactone or propranolol alone or in association.

Secondary Outcome Measures :
  1. Efficacy of spironolactone/propranolol association

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00188045


Sponsors and Collaborators
University Hospital, Angers
Investigators
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Principal Investigator: Paul Cales, PHD UH Angers
More Information
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ClinicalTrials.gov Identifier: NCT00188045    
Other Study ID Numbers: PHRC 01-13
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: December 2001
Keywords provided by University Hospital, Angers:
Portal hypertension, alcoholic cirrhosis, Hepatic venous pressure gradient, hemodynamic, spironolactone, propranolol
Additional relevant MeSH terms:
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Liver Cirrhosis, Alcoholic
Fibrosis
Pathologic Processes
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Liver Diseases, Alcoholic
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Propranolol
Spironolactone
Adrenergic beta-Antagonists
 Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents