Early Primary Prophylaxis of Esophageal Varices

N/ACompletedNCT01196507

Institute of Liver and Biliary Sciences, India140 enrolled

Overview

Patients of cirrhosis with portal hypertension aged 18 to 75 years who have small esophageal varices with or without red color signs and have not bled previously will be enrolled. After baseline evaluation, the participants will be randomized to receive either Placebo or Carvedilol 12.5 mg BD. After randomization they will be followed up for one year. The primary endpoint of the study is the the proportions of patients who develop large varices (Gd 3 or Gd 4) at 1 year in each group. The secondary endpoint are survival,reduction in HVPG,change in CTP and MELD score\& adverse events.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

140

Conditions

Cirrhosis

Interventions

CarvedilolDRUG

Carvedilol will be administered orally at a start dose of 3.125 mg twice daily. After 1 week, this will increased if systolic blood pressure does not fall below 90 mm Hg. The patient will receive the maximum tolerated dose of carvedilol or with a maximum of 12.5 BD.

PlaceboDRUG

The placebo tablets will be identical to the carvedilol tablets. First the patients will receive placebo in the dose of 1 BD. Then depending on his tolerance it will be increased to a maximum of 4 BD.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: \- Patients of cirrhosis with portal hypertension aged 18 to 75 years who have small esophageal varices with or without red color signs and have not bled previously. Exclusion Criteria: * Any contra-indication to beta-blockers * Any EVL or sclerotherapy within last 3 months * Child Turcotte Pugh (CTP) score \> 12, refractory ascites, hepatorenal syndrome * Any past history of surgery for portal hypertension * Significant cardio or pulmonary co-morbidity * Any malignancy that affects survival. * Active alcohol abuse or last intake ≤ 4 weeks to avoid possibility of ongoing alcohol hepatitis. * Past history of surgery for portal hypertension * Uncontrolled diabetes * Peripheral vascular disease * Refusal to participate in the study

Locations (1)

Institute of Liver & Biliary Sciences (ILBS)

New Delhi, National Capital Territory of Delhi, India

Outcomes

Primary Outcomes

The primary endpoint of the study is the the proportions of patients who develop large varices (Gd 3 or Gd 4) during the period of 2 year in each group.

Time frame: 2 Years

Secondary Outcomes

Survival

Time frame: 2 Years

adverse effects of drugs

Time frame: 2 Years

reduction in HVPG

Time frame: 1 Year

Data from ClinicalTrials.gov

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