Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis
- Registration Number
- NCT01212250
- Lead Sponsor
- Institute of Liver and Biliary Sciences, India
- Brief Summary
Patients of cirrhosis aged 18 to 75 years who have no esophageal varices 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 132
Inclusion Criteria
- Patients of cirrhosis aged 18 to 75 years who have no esophageal or gastric varices.
Exclusion Criteria
- Any contra-indication to beta-blockers
- Any past EVL or sclerotherapy
- Any past history of surgery for portal hypertension
- Significant cardio or pulmonary co-morbidity
- Any malignancy
- Refusal to participate in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo Placebo Placebo tablets 2 BD Carvedilol carvedilol Tablet 6.25 mg BD
- Primary Outcome Measures
Name Time Method the proportions of patients who develop esophageal varices at 1 year in each group. 1 year
- Secondary Outcome Measures
Name Time Method Number of patient dying in a period of one year 1 year Number of patients needing discontinuation of therapy due to adverse effects. 1 year Reduction in Hepatic Venous Pressure Gradient in both groups 1 year
Trial Locations
- Locations (1)
Institute of Liver & Biliary Sciences (ILBS)
š®š³New Delhi, Delhi, India