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Sponsored by: |
Govind Ballabh Pant Hospital |
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Information provided by: | Govind Ballabh Pant Hospital |
ClinicalTrials.gov Identifier: | NCT00772057 |
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. We 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 | Intervention |
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Cirrhosis |
Drug: Propranolol Drug: Placebo |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind (Subject), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Early Primary Prophylaxis With Beta-Blockers In Prevention Of Growth Of Small Esophageal Varices In Cirrhosis: A Randomized Controlled Trial |
Enrollment: | 164 |
Study Start Date: | October 2004 |
Study Completion Date: | June 2007 |
Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Propranolol group: Active Comparator |
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.
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Placebo group: Placebo Comparator |
Drug: Placebo
Placebo tablets given two times daily.
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Ages Eligible for Study: | 12 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
India, Delhi | |
Department of Gastroenterology, G B Pant Hospital | |
New Delhi, Delhi, India, 110002 |
Principal Investigator: | Shiv K Sarin, MD, DM | G B Pant Hospital |
Responsible Party: | Department of Gastroenterology, G B Pant Hospital, New Delhi, India ( Dr S K Sarin ) |
Study ID Numbers: | 2008-PHT-02 |
Study First Received: | October 14, 2008 |
Last Updated: | October 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00772057 |
Health Authority: | India: Ministry of Health |
Liver Diseases Esophageal disorder Fibrosis Gastrointestinal Diseases Liver Cirrhosis Hypertension, Portal Portal hypertension |
Esophageal varices Digestive System Diseases Propranolol Varicose Veins Esophageal and Gastric Varices Esophageal Diseases Hypertension |
Neurotransmitter Agents Vasodilator Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cardiovascular Agents Antihypertensive Agents |
Pharmacologic Actions Pathologic Processes Therapeutic Uses Adrenergic beta-Antagonists Adrenergic Antagonists Anti-Arrhythmia Agents |