Therapeutic Approach to Diastolic Dysfunction in Chronic Liver Disease Patients and Its' Impact on Morbidity and Mortality
Overview
- Phase
- Not Applicable
- Intervention
- Carvedilol
- Conditions
- Diastolic Dysfunction
- Sponsor
- Institute of Liver and Biliary Sciences, India
- Enrollment
- 189
- Locations
- 1
- Primary Endpoint
- Progression of cirrhosis and its complications.
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
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
Intervention: Carvedilol
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
Intervention: Ivabradine
Endoscopic Variceal Ligation (EVL)
Intervention: Endoscopic Variceal Ligation
Outcomes
Primary Outcomes
Progression of cirrhosis and its complications.
Time Frame: 1 Year
Secondary Outcomes
- 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)