Carvedilol for Pre-primary Prophylaxis of Esophageal Varices in Cirrhosis

Institute of Liver and Biliary Sciences, India

Status: Enrolling

Conditions: Cirrhosis

Treatments: Drug: carvedilol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01212250

ILBS PHT-003

Details and patient eligibility

About

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.

Enrollment: 132 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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132 participants in 2 patient groups, including a placebo group

Carvedilol

Experimental group

Description:

Tablet 6.25 mg BD

Treatment:

Drug: carvedilol

placebo

Placebo Comparator group

Description:

Placebo tablets 2 BD

Treatment:

Drug: Placebo