Ivabradine in Cirrhotic Cardiomyopathy

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

A total of 130 patients with liver cirrhosis who fulfill the criteria of the study, and who have been found to have left ventricular diastolic dysfunction on a screening 2D echocardiography, will then be randomized by Block randomization technique, to two arms in a ratio 1:1(Group A) will receive carvedilol+ Ivabradine targeted therapy for heart rate reduction while Group B will receive Carvedilol alone; and the dosage of drug in the treatment arm will be titrated every week to achieve target heart rate of 50-60/ minute. Patients in the treatment arms, who are unable to tolerate carvedilol due to hypotension episodes, will be offered ivabradine alone to allow achievement of targeted heart rate reduction. All patients will be evaluated at 0,6, and 12 months. The end points will be clinical events, cardiac function improvement, renal function, and mortality.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Postgraduate Institute of Medical Education and Research
• Treatments: Adrenergic beta-Antagonists; Carvedilol

Criteria

Inclusion Criteria:

• Age range of 18-65 years

• Cirrhosis, as diagnosed by histology or clinical, laboratory and USG findings,

• LV diastolic dysfunction on 2D echocardiography

Exclusion Criteria:

• Chronic renal disease

• Patient already on beta blocker

• 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