Diastolic Dysfunction, Chronic Liver Disease
Conditions
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).
Interventions
DRUGCarvedilol
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.
DRUGIvabradine
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
PROCEDUREEndoscopic Variceal Ligation
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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 * Portal vein thrombosis * Transjugular intrahepatic porto systemic shunt (TIPS) insertion * Hepatocellular carcinoma * Anemia Hb \< 8gm/dl in females, and \< 9 gm/dl in males
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression of cirrhosis and its complications. | 1 Year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Renal function | 1 Year | Renal function is being checked- urea, creatinine, urine sediment, and creatinine clearance as calculated by Cockcroft - Gault formula |
| Serum level of Brain Natriuretic Peptide. | 1 Year | — |
| Mortality | 1 Year | — |
| Improvement in left ventricular diastolic function in either arm. | 1 Year | — |
| Electrophysiologic modifications | 1 Year | Electrophysiological changes checked are QTc interval, documentation of arrhythmias |
| Serum level of catecholamines | 1 year | — |
| Serum level of plasma renin activity | 1 Year | — |
| Quality of life | 1 Year | — |
Countries
India
Outcome results
None listed