A Study to Prevent Complications of High Blood Pressure Caused by Hepatitis in Patients With Cirrhosis
I. Evaluate the efficacy of a certain drug in preventing intestinal complications in patients with cirrhosis and high blood pressure in the hepatic portal vein.
II. Evaluate vein pressure measurements to predict the development of internal bleeding.
Esophageal and Gastric Varices
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Primary Purpose: Prevention
|Official Title:||Randomized, Double-Blind Study of Timolol (A Nonselective Beta-Adrenergic Blocker) vs Placebo to Prevent Complications of Hepatic Portal Hypertension in Patients With Cirrhosis|
|Study Start Date:||May 1993|
|Primary Completion Date:||August 2007 (Final data collection date for primary outcome measure)|
PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution, cirrhosis etiology, and hepatic venous pressure gradient.
The dose of oral timolol is titrated over 28 days. Patients are then randomly assigned to daily timolol at the titrated dose or a placebo if successful titration is achieved by day 28, and the final titration dose is maintained for at least 10 days. Timolol is discontinued prior to randomization.
Criteria for removal from study include esophageal or gastric varices, significant bleeding or hemorrhage, timolol-induced hepatic encephalopathy, and liver transplantation.
Patients are followed every 3 months.
|United States, Connecticut|
|Yale University School of Medicine|
|New Haven, Connecticut, United States, 06510|
|Study Chair:||Robert J. Groszmann||Yale University|