Clinical trial NCT02465645: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cirrhosis With Esophageal Varices
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2015-06-08
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Total number of patients who will be Responders.
timeFrame: 3 Months
Secondary outcomes:
measure: Total number of patients develop esophageal variceal bleed
timeFrame: 3 months
measure: Total number of patients develop PHG (Portal Hypertensive Gastropathy).
timeFrame: 3 months
measure: Total number of patients develop GAVE (Gastric Antral Vascular Ectasia).
timeFrame: 3 months
measure: Total number of patients develop Gastric Varices.
timeFrame: 3 months
measure: Total number of patients develop adverse Events of the study drug
timeFrame: 3 months
measure: Improvement in the CTP (Child-Turcotte-Pugh score) score.
timeFrame: 3 months
measure: Improvement in the MELD (Model for End Stage liver Disease) score.
timeFrame: 3 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences
state: Delhi
Study officials:
affiliation: Institute of Liver and Biliary Sciences
name: Dr V Rajan, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.