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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00772057
Recruitment Status : Completed
First Posted : October 15, 2008
Last Update Posted : December 21, 2009
Sponsor:
Information provided by:

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.


Condition or disease Intervention/treatment
Cirrhosis Drug: Propranolol Drug: Placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Early Primary Prophylaxis With Beta-Blockers In Prevention Of Growth Of Small Esophageal Varices In Cirrhosis: A Randomized Controlled Trial
Study Start Date : October 2004
Primary Completion Date : October 2008
Study Completion Date : October 2008


Arms and Interventions

Arm Intervention/treatment
Active Comparator: Propranolol group 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.
Placebo Comparator: Placebo group Drug: Placebo
Placebo tablets given two times daily.


Outcome Measures

Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00772057


Locations
India
Department of Gastroenterology, G B Pant Hospital
New Delhi, Delhi, India, 110002
Sponsors and Collaborators
Govind Ballabh Pant Hospital
Investigators
Principal Investigator: Shiv K Sarin, MD, DM G B Pant Hospital
More Information

Responsible Party: Dr S K Sarin, Department of Gastroenterology, G B Pant Hospital, New Delhi, India
ClinicalTrials.gov Identifier: NCT00772057     History of Changes
Other Study ID Numbers: 2008-PHT-02
First Posted: October 15, 2008    Key Record Dates
Last Update Posted: December 21, 2009
Last Verified: October 2008

Additional relevant MeSH terms:
Fibrosis
Liver Cirrhosis
Esophageal and Gastric Varices
Pathologic Processes
Liver Diseases
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Hypertension, Portal
Propranolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents