A Prospective Randomized Study to Compare the Efficacy and Safety of Carvedilol With or Without Simvastatin in Patients With Portal Hypertension and Esophageal Varices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Total number of patients who will be Responders.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients of chronic liver disease with esophageal varices.
- •Age more than and equal to 18 years.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Carvedilol + Simvastatin (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.
干预措施: Carvedilol (Drug)
结局指标
主要结局
Total number of patients who will be Responders.
时间窗: 3 Months
Responders (Absolute value of HVPG\<12 mm Hg or HVPG≥20% reduction)
次要结局
- Total number of patients develop PHG (Portal Hypertensive Gastropathy).(3 months)
- 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 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)