- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00188045
Hemodynamic Effects of Chronic Administration of Spironolactone and/or Propranolol in Alcoholic Cirrhotic Patients
October 30, 2017 updated by: University Hospital, Angers
Hemodynamic Effects of Chronic Administration of Spironolactone, Propranolol and Their Association in Alcoholic Cirrhotic Patients
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
54
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
assessment of hepatic veinous pressure gradient changes after chronic treatment by spironolactone or propranolol alone or in association.
|
Secondary Outcome Measures
Outcome Measure |
---|
Efficacy of spironolactone/propranolol association
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Paul Cales, PHD, UH Angers
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 1995
Study Completion
December 1, 2003
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 16, 2005
Study Record Updates
Last Update Posted (Actual)
November 1, 2017
Last Update Submitted That Met QC Criteria
October 30, 2017
Last Verified
December 1, 2001
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Digestive System Diseases
- Pathologic Processes
- Alcohol-Related Disorders
- Substance-Related Disorders
- Liver Diseases
- Liver Diseases, Alcoholic
- Alcohol-Induced Disorders
- Liver Cirrhosis
- Fibrosis
- Liver Cirrhosis, Alcoholic
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Vasodilator Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Natriuretic Agents
- Diuretics
- Hormone Antagonists
- Mineralocorticoid Receptor Antagonists
- Diuretics, Potassium Sparing
- Propranolol
- Spironolactone
Other Study ID Numbers
- PHRC 01-13
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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