Esophageal and Gastric Varices, Liver Cirrhosis, Portal Hypertension
Conditions
Keywords
cirrhosis, esophageal varices, variceal hemorrhage, beta-adrenergic blocker
Brief summary
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).
Interventions
DRUGTimolol Maleate
DRUGPlacebo
Sponsors
Yale University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Varices | 6 years | Development of varices |
Countries
Spain, United Kingdom, United States
Outcome results
None listed