Back to resultsBeta-blockers for Prevention Of Growth Of Small Esophageal Varices In Cirrhosis: An Randomized Controlled Trial (RCT)
Primary Purpose
Cirrhosis
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Propranolol
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Cirrhosis
Eligibility Criteria
Inclusion Criteria:
- A clinical, radiological or histologic diagnosis of cirrhosis was made
- Age was between 18 and 70 years
- Esophageal varices were small (i.e. ≤5 mm or of grade 1 or 2 according to Conn et al).
Exclusion Criteria:
- Presence of previous variceal bleeding
- Previous medical, surgical or endoscopic treatment for portal hypertension
- Child-Pugh score >13
- Neoplastic disease of any site
- Splenic or portal vein thrombosis
- Concurrent illnesses expected to decrease life expectancy to less than one year
- Pregnancy
- Contraindication to beta-blockers (atrioventricular block, sinus bradycardia with heart rate <50 beats per minute, arterial hypotension with systolic blood pressure <90 mm Hg, heart failure, asthma, peripheral arterial disease, or diabetes needing insulin treatment)
- Concurrent anti-viral treatment during the study period
- Inability to perform follow-up
- Failure to give consent to participate in the study.
Sites / Locations
- Department of Gastroenterology, G B Pant Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Propranolol group
Placebo group
Arm Description
Outcomes
Primary Outcome Measures
The primary endpoint of the study was the development of large (>5 mm) esophageal varices (grade 3 or 4 by Conn's classification)
Secondary Outcome Measures
Secondary endpoints were variceal bleeding, death, adverse effects of beta blockers, and hemodynamic response to beta-blocker in patients who underwent serial HVPG
Full Information
NCT ID
NCT00772057
First Posted
October 14, 2008
Last Updated
December 18, 2009
Sponsor
Govind Ballabh Pant Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00772057
Brief Title
Beta-blockers for Prevention Of Growth Of Small Esophageal Varices In Cirrhosis: An Randomized Controlled Trial (RCT)
Official Title
Early Primary Prophylaxis With Beta-Blockers In Prevention Of Growth Of Small Esophageal Varices In Cirrhosis: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Govind Ballabh Pant Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
164 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Propranolol group
Arm Type
Active Comparator
Arm Title
Placebo group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Propranolol
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets given two times daily.
Primary Outcome Measure Information:
Title
The primary endpoint of the study was the development of large (>5 mm) esophageal varices (grade 3 or 4 by Conn's classification)
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Secondary endpoints were variceal bleeding, death, adverse effects of beta blockers, and hemodynamic response to beta-blocker in patients who underwent serial HVPG
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A clinical, radiological or histologic diagnosis of cirrhosis was made
Age was between 18 and 70 years
Esophageal varices were small (i.e. ≤5 mm or of grade 1 or 2 according to Conn et al).
Exclusion Criteria:
Presence of previous variceal bleeding
Previous medical, surgical or endoscopic treatment for portal hypertension
Child-Pugh score >13
Neoplastic disease of any site
Splenic or portal vein thrombosis
Concurrent illnesses expected to decrease life expectancy to less than one year
Pregnancy
Contraindication to beta-blockers (atrioventricular block, sinus bradycardia with heart rate <50 beats per minute, arterial hypotension with systolic blood pressure <90 mm Hg, heart failure, asthma, peripheral arterial disease, or diabetes needing insulin treatment)
Concurrent anti-viral treatment during the study period
Inability to perform follow-up
Failure to give consent to participate in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiv K Sarin, MD, DM
Organizational Affiliation
G B Pant Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gastroenterology, G B Pant Hospital
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110002
Country
India
12. IPD Sharing Statement
Learn more about this trial
Beta-blockers for Prevention Of Growth Of Small Esophageal Varices In Cirrhosis: An Randomized Controlled Trial (RCT)
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