Hemodynamic Effects of Chronic Administration of Spironolactone and/or Propranolol in Alcoholic Cirrhotic Patients
This study has been terminated.
Sponsor:
University Hospital, Angers
Information provided by:
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT00188045
First received: September 12, 2005
Last updated: December 28, 2005
Last verified: December 2001
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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:
Genetics Home Reference related topics:
North American Indian childhood cirrhosis
MedlinePlus related topics:
Cirrhosis
U.S. FDA Resources
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00188045
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, Alcoholic Alcohol-Induced Disorders Alcohol-Related Disorders Chemically-Induced Disorders Digestive System Diseases Liver Cirrhosis Liver Diseases Liver Diseases, Alcoholic Substance-Related Disorders Propranolol Spironolactone Adrenergic Agents Adrenergic Antagonists Adrenergic beta-Antagonists Anti-Arrhythmia Agents |
Antihypertensive Agents Cardiovascular Agents Diuretics Diuretics, Potassium Sparing Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Mineralocorticoid Receptor Antagonists Molecular Mechanisms of Pharmacological Action Natriuretic Agents Neurotransmitter Agents Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses Vasodilator Agents |
ClinicalTrials.gov processed this record on March 03, 2015