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Home > "P" Clinical Trials Conditions > Prevention of Esophageal Varices by Beta-Adrenergic Blockers  Prevention of Esophageal Varices by Beta-Adrenergic Blockers
Prevention of Esophageal Varices by Beta-Adrenergic Blockers
For Condition: Portal Hypertension,Liver Cirrhosis,Esophageal and Gastric Varices
Status: Completed
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ,
Synopsis: The purpose of this study is to learn whether timolol is useful in preventing or delaying the appearance of gastroesophageal varices, a complication that may develop in the future as a consequence of liver disease. Cirrhosis causes an increased resistance of blood flowing through the liver. This leads to an increased pressure in the portal vein (the vein that takes blood to your liver). High portal pressure is responsible for the appearance of complications of chronic liver disease such as varices and variceal bleeding (bleeding from veins in your esophagus). Timolol belongs to a group of medications called beta-blockers. Beta-blockers decrease high portal pressure and previous studies have shown that beta-blocker pills are useful in preventing bleeding from varices in patients who already have varices. A more desirable effect would be if these pills could prevent not only bleeding from varices but the appearance of varices (and therefore of bleeding).
Details:
Eligibility:
Study Type: Interventional, Prevention, Double-Blind
Minimum Age/Maximum Age: 18 Years/75 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Liver biopsy compatible with cirrhosis. - Absence of gastroesophageal varices. - An increased hepatic venous pressure gradient (HVPG) (6mmHg). - Age over 18 and below 76 years. - Informed, written consent. - Absence of exclusion criteria. Exclusion Criteria: - Presence of ascites that requires specific treatment (diuretics, paracentesis, peritoneo-venous shunt, etc). - Proven hepatocellular carcinoma by radiological or histological criteria. - Splenic or portal vein thrombosis by Doppler-ultrasound. - Presence of any concurrent disease that is expected to decrease life expectancy to less than one year. - Patients taking diuretics, beta-blockers, clonidine, prazosin, nitrates, molsidomine and any drug which may have an effect on splanchnic hemodynamics/portal pressure. - Patients participating in other pharmacological randomized clinical trials. - Patients with primary biliary cirrhosis and primary sclerosing cholangitis will also be excluded since these entities have a slower progression of the disease, are usually enrolled in other clinical trials and are transplanted at an earlier stage. - Contraindications to beta-blockers: asthma, COPD with positive broncoconstrictive test, heart failure, A-V block, aortic valve stenosis, organic psychosis, insulin-dependent diabetes, hypersensitivity to beta-blockers. - Women who are pregnant, nursing or of childbearing potential and who are not using oral or mechanical contraception.
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertoGroszmann, Principal Investigator, Yale University School of Med.
The Faulkner Hospital
Boston, Massachusetts, 02130
United States
VA CT Healthcare System
West Haven, Connecticut, 06516
United States
Yale University Sch. of Medicine
New Haven, Connecticut, 06520
United States
Hospital Clinic I Provincial de Barcelona
Barcelona, Catalonia,
Spain
Royal Free Hospital
Hampstead, London, NW32QG
United Kingdom
Additional Information:
Study ID Numbers: Timolol; 6618,YALESM,RO1 DK46580
Study Start Date: August 1993
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006398
Other Portal Hypertension Studies:
1. Prevention of Esophageal Varices by Beta-Adrenergic Blockers
2. Phase II Study of Lactulose and Circadian Rhythms in Patients with Cirrhosis
Related Studies:
Other Portal Hypertension Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Prevention of Esophageal Varices by Beta-Adrenergic Blockers
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