Hemodynamic Effects of Chronic Administration of Spironolactone and/or Propranolol in Alcoholic Cirrhotic Patients
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ClinicalTrials.gov Identifier: NCT00188045 |
Recruitment Status :
Terminated
First Posted : September 16, 2005
Last Update Posted : November 1, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alcoholic Cirrhosis | Drug: Propranolol - Spironolactone | Phase 4 |
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 |

- assessment of hepatic veinous pressure gradient changes after chronic treatment by spironolactone or propranolol alone or in association.
- Efficacy of spironolactone/propranolol association

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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 |
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

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
Principal Investigator: | Paul Cales, PHD | UH Angers |
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 |
Portal hypertension, alcoholic cirrhosis, Hepatic venous pressure gradient, hemodynamic, spironolactone, propranolol |
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 |