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

A Prospective Randomized Study to Compare the Efficacy and Safety of Carvedilol With or Without Simvastatin in Patients With Portal Hypertension and Esophageal Varices

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02465645

Enrollment

220

Registered

2015-06-08

Start date

2015-06-01

Completion date

2017-01-31

Last updated

2018-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis With Esophageal Varices

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.

Interventions

DRUGCarvedilol

DRUGCarvedilol + Simvastatin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Total number of patients who will be Responders.	3 Months	Responders (Absolute value of HVPG\<12 mm Hg or HVPG≥20% reduction)

Secondary

Measure	Time frame
Total number of patients develop PHG (Portal Hypertensive Gastropathy).	3 months
Total number of patients develop GAVE (Gastric Antral Vascular Ectasia).	3 months
Total number of patients develop Gastric Varices.	3 months
Total number of patients develop esophageal variceal bleed	3 months
Improvement in the CTP (Child-Turcotte-Pugh score) score.	3 months
Improvement in the MELD (Model for End Stage liver Disease) score.	3 months
Total number of patients develop adverse Events of the study drug	3 months

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026