MedTrace Logo

Beta-blockers for Prevention Of Growth Of Small Esophageal Varices In Cirrhosis: An Randomized Controlled Trial (RCT)

NCT00772057 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2009-12-21

No results posted yet for this study

Summary

Background and Aims: The efficacy of portal pressure reduction by beta blockers for the management of small (≤5 mm) esophageal varices in patients of cirrhosis is not clear. The present randomized controlled trial aims to address these issues. The investigators also assessed the utility of serial HVPG measurements in these patients.

Patients and Methods: Consecutive patients with cirrhosis with small varices, with no history of variceal bleed, were randomized to receive propranolol or placebo. These patients were further randomized to undergo no HVPG, only baseline HVPG, or serial HVPG measurement. Propranolol was titrated to reduce heart-rate to 55/min.

Conditions

  • Cirrhosis

Interventions

DRUG

Propranolol

Beta-blocker (propranolol) was started at a dose of 20 mg twice daily. The principle of incremental dosing was used to achieve the target heart rate for propranolol. The dose was increased every alternate day to achieve a target heart rate of 55/min or to the maximal dose to 360 mg/day if the medication was well tolerated and the systolic blood pressure was \>90 mm Hg. On the occurrence of intolerable adverse effects, systolic blood pressure \<90 mm Hg or pulse rate \<55/min, the dose of the medication was decreased step-wise, and eventually stopped if these adverse events persisted. Reintroduction of the medication was attempted if cessation of the medication did not result in improvement of the reported side-effect.

DRUG

Placebo

Placebo tablets given two times daily.

Sponsors & Collaborators

  • Govind Ballabh Pant Hospital

    lead OTHER_GOV

Principal Investigators

  • Shiv K Sarin, MD, DM · G B Pant Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-10-31
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • India

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00772057 on ClinicalTrials.gov