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

Chronic Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02294292
• Other study ID #: ILBS-CLD-DD-01
• Status: Completed
• Phase: N/A
• First received: June 9, 2014
• Last updated: February 6, 2018
• Start date: July 1, 2014
• Est. completion date: August 31, 2016

Study information

• Verified date: February 2016
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: August 31, 2016
• Est. primary completion date: August 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Liver Disease
• Diastolic Dysfunction
• Liver Diseases

Intervention

Drug:
• Carvedilol
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.
• 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

Procedure:
• Endoscopic Variceal Ligation

Locations

Country	Name	City	State
India	Institute of Liver & Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression of cirrhosis and its complications.		1 Year
Secondary	Improvement in left ventricular diastolic function in either arm.		1 Year
Secondary	Renal function	Renal function is being checked- urea, creatinine, urine sediment, and creatinine clearance as calculated by Cockcroft - Gault formula	1 Year
Secondary	Serum level of Brain Natriuretic Peptide.		1 Year
Secondary	Mortality		1 Year
Secondary	Quality of life		1 Year
Secondary	Electrophysiologic modifications	Electrophysiological changes checked are QTc interval, documentation of arrhythmias	1 Year
Secondary	Serum level of catecholamines		1 year
Secondary	Serum level of plasma renin activity		1 Year