Carvedilol to prevent esophageal varices in people with cirrhosis
Official title: A Prospective, Double-blind, Randomized Placebo-controlled Trial of Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis
Run by Institute of Liver and Biliary Sciences, India · NCT01212250 · Data updated 2026-11-12
This will try whether taking carvedilol twice daily for one year can prevent esophageal varices in adults (18–75) with cirrhosis who do not currently have varices, compared with a placebo.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 132 (estimated) |
| Sponsor | Institute of Liver and Biliary Sciences, India Academic / other |
| Locations | 1 site (New Delhi, National Capital Territory of Delhi) |
| Status | Recruiting |
| Started | September 1, 2010 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | August 13, 2025 |
| Trial ID | NCT01212250 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–75 with cirrhosis who currently have no esophageal or gastric varices and who have no contraindications to beta-blockers are ideal candidates for this study.
✕Probably not a fit
Patients with contraindications to beta-blockers, prior endoscopic or surgical treatment for portal hypertension, significant cardio-pulmonary comorbidity, or active malignancy are unlikely to be eligible or to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, randomized, placebo-controlled interventional trial enrolling adults with cirrhosis but no esophageal or gastric varices. After baseline evaluation participants are randomized to carvedilol 12.5 mg twice daily or matching placebo and followed for one year with periodic clinical assessments. Major exclusions include contraindications to beta-blockers, prior endoscopic variceal treatment or surgery for portal hypertension, significant cardiopulmonary disease, or malignancy. The study is conducted at the Institute of Liver & Biliary Sciences (ILBS) in New Delhi.
Why it matters
Potential benefit: If successful, carvedilol could delay or prevent the development of esophageal varices and thereby reduce the future risk of variceal bleeding in patients with cirrhosis.
How similar studies have gone: Carvedilol has shown effectiveness in lowering portal pressure and in secondary prevention of variceal bleeding, but using it specifically to prevent the first occurrence of varices is less well established.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, National Capital Territory of Delhi, India Recruiting
Study contacts
- Study coordinator: Dr Ankur Jindal, DM
- Email: ankur.jindal3@gmail.com
- Phone: 011-46300000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.