Therapeutic Approach to Diastolic Dysfunction in Chronic Liver Disease Patients and Its Impact on Morbidity and Mortality

Institute of Liver and Biliary Sciences, India

Status: Completed

Conditions: Diastolic Dysfunction; Chronic Liver Disease

Treatments: Procedure: Endoscopic Variceal Ligation; Drug: Carvedilol; Drug: Ivabradine

Study type: Interventional

Funder types: Other

Identifiers

NCT02294292

ILBS-CLD-DD-01

Details and patient eligibility

About

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).

Enrollment: 189 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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189 participants in 2 patient groups

Carvedilol + Ivabradine

Experimental group

Description:

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

Treatment:

Drug: Carvedilol

Drug: Ivabradine

Endoscopic Variceal Ligation (EVL)

Active Comparator group

Treatment:

Procedure: Endoscopic Variceal Ligation