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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-01

Study Completion Date

2017-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cirrhosis With Esophageal Varices

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Carvedilol + 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.

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.

Group Type EXPERIMENTAL

Carvedilol + Simvastatin

Intervention Type DRUG

Carvedilol

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.

Group Type ACTIVE_COMPARATOR

Carvedilol

Intervention Type DRUG

Interventions

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Carvedilol

Intervention Type DRUG

Carvedilol + Simvastatin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No