To Compare the Efficacy and Safety of Carvedilol With or Without Simvastatin in Patients With Portal Hypertension and Esophageal Varices.
Not Applicable
Completed
- Conditions
- Cirrhosis With Esophageal Varices
- Interventions
- Registration Number
- NCT02465645
- Lead Sponsor
- Institute of Liver and Biliary Sciences, India
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 220
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Carvedilol + Simvastatin 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. Carvedilol 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.
- Primary Outcome Measures
Name Time Method Total number of patients who will be Responders. 3 Months Responders (Absolute value of HVPG\<12 mm Hg or HVPG≥20% reduction)
- Secondary Outcome Measures
Name Time Method Total number of patients develop Gastric Varices. 3 months Improvement in the MELD (Model for End Stage liver Disease) score. 3 months Total number of patients develop esophageal variceal bleed 3 months Total number of patients develop PHG (Portal Hypertensive Gastropathy). 3 months Total number of patients develop adverse Events of the study drug 3 months Improvement in the CTP (Child-Turcotte-Pugh score) score. 3 months Total number of patients develop GAVE (Gastric Antral Vascular Ectasia). 3 months
Trial Locations
- Locations (1)
Institute of Liver and Biliary Sciences
🇮🇳New Delhi, Delhi, India