Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: carvedilol, Placebo.
- Who it may be relevant to
- Registry conditions: Cirrhosis. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective, Double-blind, Randomized Placebo-controlled Trial of Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis
Overview
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
- Drug carvedilol
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. - Drug Placebo
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.
Primary outcome measures
- the proportions of patients who develop esophageal varices at 1 year in each group. [Time frame: 1 year]
Secondary outcome measures (3)
- Number of patient dying in a period of one year [Time frame: 1 year]
- Number of patients needing discontinuation of therapy due to adverse effects. [Time frame: 1 year]
- Reduction in Hepatic Venous Pressure Gradient in both groups [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
India · 1 center
- Institute of Liver & Biliary Sciences (ILBS) — New Delhi
Identifiers
NCT: NCT01212250 · ILBS PHT-003