Cirrhosis
Conditions
Brief summary
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.
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 or with a maximum of 12.5 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 4 BD.
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 2 Years |
Secondary
| Measure | Time frame |
|---|---|
| Survival | 2 Years |
| adverse effects of drugs | 2 Years |
| reduction in HVPG | 1 Year |
Countries
India
Outcome results
None listed