Cirrhosis
Conditions
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.
Interventions
DRUGcarvedilol
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 with a maximum of 6.25 BD.
DRUGPlacebo
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 2 BD.
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the proportions of patients who develop esophageal varices at 1 year in each group. | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
India
Contacts
Primary ContactDr Ankur Jindal, DM
Backup ContactDr Ankit Bhardwaj, PhD (Epidemiology)
Outcome results
None listed