Therapeutic Approach to Diastolic Dysfunction in Chronic Liver Disease Patients and Its' Impact on Morbidity and Mortality
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 189
- 试验地点
- 1
- 主要终点
- Progression of cirrhosis and its complications.
研究概览
简要总结
Cirrhotic cardiomyopathy is defined as a chronic cardiac dysfunction in patients with cirrhosis. It is suspected that this specific cardiac dysfunction contributes to the onset of complications in liver disease. The purpose of this prospective, randomized controlled trial is to determine whether carvedilol can revert cardiac dysfunction i.e. left ventricular diastolic dysfunction secondary to cirrhosis, and prevent complications (renal dysfunction, worsening cardiac function, and mortality).
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with cirrhosis who have been diagnosed by clinical, biochemical,or histological (when available) criteria plus ultrasound imaging.
- •Age range of 18-60 years
- •Cirrhosis as diagnosed by histology or clinical, laboratory and USG (UltraSonography) findings,
- •Upper GI bleed who are undergoing secondary endoscopic variceal ligation for eradication of varices
排除标准
- •Age >60 years
- •Chronic renal disease
- •Pregnancy and peripartum cardiomyopathy
- •Hypertension
- •Coronary artery disease
- •Valvular heart disease
- •Sick sinus syndrome/ Pacemaker
- •Cardiac rhythm disorder
- •Hypothyroidism
- •Hyperthyroidism
- •Portal vein thrombosis
- •Transjugular intrahepatic porto systemic shunt (TIPS) insertion
- •Hepatocellular carcinoma
- •Anemia Hb < 8gm/dl in females, and < 9 gm/dl in males
研究组 & 干预措施
Carvedilol + Ivabradine
Carvedilol started to achieve target HR (heart rate) reduction to 60/min, to a lowest permissible 50-55/ min ; provided Systolic Blood Pressure> 90 mmHg.
if carvedilol is not tolerated,Ivabradine is added in a dose starting 2.5 mg BD to a maximum of 15 mg/day to ensure targeted heart rate reduction
干预措施: Carvedilol (Drug)
Carvedilol + Ivabradine
Carvedilol started to achieve target HR (heart rate) reduction to 60/min, to a lowest permissible 50-55/ min ; provided Systolic Blood Pressure> 90 mmHg.
if carvedilol is not tolerated,Ivabradine is added in a dose starting 2.5 mg BD to a maximum of 15 mg/day to ensure targeted heart rate reduction
干预措施: Ivabradine (Drug)
Endoscopic Variceal Ligation (EVL)
干预措施: Endoscopic Variceal Ligation (Procedure)
结局指标
主要结局
Progression of cirrhosis and its complications.
时间窗: 1 Year
次要结局
- Serum level of Brain Natriuretic Peptide.(1 Year)
- Mortality(1 Year)
- Quality of life(1 Year)
- Improvement in left ventricular diastolic function in either arm.(1 Year)
- Renal function(1 Year)
- Electrophysiologic modifications(1 Year)
- Serum level of catecholamines(1 year)
- Serum level of plasma renin activity(1 Year)