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To Compare the Efficacy and Safety of Carvedilol With or Without Simvastatin in Patients With Portal Hypertension and Esophageal Varices.

Primary Purpose

Cirrhosis With Esophageal Varices

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Carvedilol
Carvedilol + Simvastatin
Sponsored by
Institute of Liver and Biliary Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cirrhosis With Esophageal Varices

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. All patients of chronic liver disease with esophageal varices.
  2. Age more than and equal to 18 years.

Exclusion Criteria:

  1. Patients of chronic liver disease with history of upper Gastro Intestinal bleed.
  2. Patients of acute on chronic liver failure
  3. Thrombosis of splenoportal axis
  4. Hepatocellular carcinoma
  5. Patients who were on primary variceal ligation sessions as prophylaxis
  6. Patients who are beta blocker intolerant (Prior h/o hypotension, bradycardia).
  7. Patients who are contraindicated for beta blockers {H/O COPD (Coronary Obstructive Pulmonary Disease), heart block, refractory Ascites, SBP(Spontaneous Bacterial Peritonitis) , HRS(Hepato Renal Syndrome)}.
  8. Failure to give consent for inclusion in the study

Sites / Locations

  • Institute of Liver and Biliary Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Carvedilol + Simvastatin

Carvedilol

Arm Description

Carvedilol will be administered orally at a start dose of 3.125 mg twice daily per day. After 1 week, this will increased to a dose of 6.25 mg twice daily per day. Target dose of 12.5 mg twice daily per day will be started after 2 weeks if systolic blood pressure does not fall below 90 mm Hg and HR 55-60/min. Simvastatin will be administered orally at a start dose of 20 mg for 15 days followed by 40 mg OD for the next 3 months. Along with Simvastatin, Carvedilol will be administered orally at a start dose of 3.125 mg twice daily per day. After 1 week, this will increased to a dose of 6.25 mg twice daily per day. Target dose of 12.5 mg twice daily per day will be started after 2 weeks if systolic blood pressure does not fall below 90 mm Hg and HR 55-60/min.

Carvedilol will be administered orally at a start dose of 3.125 mg twice daily per day. After 1 week, this will increased to a dose of 6.25 mg twice daily per day. Target dose of 12.5 mg twice daily per day will be started after 2 weeks if systolic blood pressure does not fall below 90 mm Hg and HR 55-60/min.

Outcomes

Primary Outcome Measures

Total number of patients who will be Responders.
Responders (Absolute value of HVPG<12 mm Hg or HVPG≥20% reduction)

Secondary Outcome Measures

Total number of patients develop esophageal variceal bleed
Total number of patients develop PHG (Portal Hypertensive Gastropathy).
Total number of patients develop GAVE (Gastric Antral Vascular Ectasia).
Total number of patients develop Gastric Varices.
Total number of patients develop adverse Events of the study drug
Improvement in the CTP (Child-Turcotte-Pugh score) score.
Improvement in the MELD (Model for End Stage liver Disease) score.

Full Information

First Posted
June 4, 2015
Last Updated
May 10, 2018
Sponsor
Institute of Liver and Biliary Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT02465645
Brief Title
To Compare the Efficacy and Safety of Carvedilol With or Without Simvastatin in Patients With Portal Hypertension and Esophageal Varices.
Official Title
A Prospective Randomized Study to Compare the Efficacy and Safety of Carvedilol With or Without Simvastatin in Patients With Portal Hypertension and Esophageal Varices
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
June 1, 2015 (Actual)
Primary Completion Date
January 31, 2017 (Actual)
Study Completion Date
January 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
After successful screening of patients based on inclusion criteria, we will measure the baseline Hepatic Venous Pressure Gradient. At day 1 patients will undergo complete blood investigation including complete haemogram, kidney function test, liver function test, prothrombin time, AFP (Alfa Feto Protein) level, chest x ray, ultrasonography, fibroscan. Routine complete physical examination will be done.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis With Esophageal Varices

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carvedilol + Simvastatin
Arm Type
Experimental
Arm Description
Carvedilol will be administered orally at a start dose of 3.125 mg twice daily per day. After 1 week, this will increased to a dose of 6.25 mg twice daily per day. Target dose of 12.5 mg twice daily per day will be started after 2 weeks if systolic blood pressure does not fall below 90 mm Hg and HR 55-60/min. Simvastatin will be administered orally at a start dose of 20 mg for 15 days followed by 40 mg OD for the next 3 months. Along with Simvastatin, Carvedilol will be administered orally at a start dose of 3.125 mg twice daily per day. After 1 week, this will increased to a dose of 6.25 mg twice daily per day. Target dose of 12.5 mg twice daily per day will be started after 2 weeks if systolic blood pressure does not fall below 90 mm Hg and HR 55-60/min.
Arm Title
Carvedilol
Arm Type
Active Comparator
Arm Description
Carvedilol will be administered orally at a start dose of 3.125 mg twice daily per day. After 1 week, this will increased to a dose of 6.25 mg twice daily per day. Target dose of 12.5 mg twice daily per day will be started after 2 weeks if systolic blood pressure does not fall below 90 mm Hg and HR 55-60/min.
Intervention Type
Drug
Intervention Name(s)
Carvedilol
Intervention Type
Drug
Intervention Name(s)
Carvedilol + Simvastatin
Primary Outcome Measure Information:
Title
Total number of patients who will be Responders.
Description
Responders (Absolute value of HVPG<12 mm Hg or HVPG≥20% reduction)
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Total number of patients develop esophageal variceal bleed
Time Frame
3 months
Title
Total number of patients develop PHG (Portal Hypertensive Gastropathy).
Time Frame
3 months
Title
Total number of patients develop GAVE (Gastric Antral Vascular Ectasia).
Time Frame
3 months
Title
Total number of patients develop Gastric Varices.
Time Frame
3 months
Title
Total number of patients develop adverse Events of the study drug
Time Frame
3 months
Title
Improvement in the CTP (Child-Turcotte-Pugh score) score.
Time Frame
3 months
Title
Improvement in the MELD (Model for End Stage liver Disease) score.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients of chronic liver disease with esophageal varices. Age more than and equal to 18 years. Exclusion Criteria: Patients of chronic liver disease with history of upper Gastro Intestinal bleed. Patients of acute on chronic liver failure Thrombosis of splenoportal axis Hepatocellular carcinoma Patients who were on primary variceal ligation sessions as prophylaxis Patients who are beta blocker intolerant (Prior h/o hypotension, bradycardia). Patients who are contraindicated for beta blockers {H/O COPD (Coronary Obstructive Pulmonary Disease), heart block, refractory Ascites, SBP(Spontaneous Bacterial Peritonitis) , HRS(Hepato Renal Syndrome)}. Failure to give consent for inclusion in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr V Rajan, MD
Organizational Affiliation
Institute of Liver and Biliary Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Liver and Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
32079861
Citation
Vijayaraghavan R, Jindal A, Arora V, Choudhary A, Kumar G, Sarin SK. Hemodynamic Effects of Adding Simvastatin to Carvedilol for Primary Prophylaxis of Variceal Bleeding: A Randomized Controlled Trial. Am J Gastroenterol. 2020 May;115(5):729-737. doi: 10.14309/ajg.0000000000000551.
Results Reference
derived

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To Compare the Efficacy and Safety of Carvedilol With or Without Simvastatin in Patients With Portal Hypertension and Esophageal Varices.

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