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

This study has been terminated.
Sponsor:
Information provided by:
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT00188045
First received: September 12, 2005
Last updated: December 28, 2005
Last verified: December 2001
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Hemodynamic Effects of Chronic Administration of Spironolactone, Propranolol and Their Association in Alcoholic Cirrhotic Patients

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov Identifier: NCT00188045     History of Changes
Other Study ID Numbers: PHRC 01-13
Study First Received: September 12, 2005
Last Updated: December 28, 2005
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 Cirrhosis
Fibrosis
Liver Cirrhosis, Alcoholic
Liver Diseases
Digestive System Diseases
Pathologic Processes
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
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Vasodilator Agents
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Diuretics, Potassium Sparing
Diuretics

ClinicalTrials.gov processed this record on September 14, 2014