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

Institute of Liver and Biliary Sciences, India

Status: Completed

Conditions: Cirrhosis With Esophageal Varices

Treatments: Drug: Carvedilol; Drug: Carvedilol + Simvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02465645

ILBS-Cirrhosis-004

Details and patient eligibility

About

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.

Enrollment: 220 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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220 participants in 2 patient groups

Carvedilol + Simvastatin

Experimental group

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.

Treatment:

Drug: Carvedilol + Simvastatin

Carvedilol

Active Comparator group

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.

Treatment:

Drug: Carvedilol