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Completed

NCT Number: NCT02294292

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

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).

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Key information

Conditions

Diastolic Dysfunction Chronic Liver Disease

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carvedilol

Drug

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

Drug

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

Endoscopic Variceal Ligation

Procedure

Primary outcomes

  1. Progression of cirrhosis and its complications.

    Time frame: 1 Year

Secondary outcomes

  1. Improvement in left ventricular diastolic function in either arm.

    Time frame: 1 Year

  2. Renal function

    Time frame: 1 Year

    Renal function is being checked- urea, creatinine, urine sediment, and creatinine clearance as calculated by Cockcroft - Gault formula

  3. Serum level of Brain Natriuretic Peptide.

    Time frame: 1 Year

  4. Mortality

    Time frame: 1 Year

  5. Quality of life

    Time frame: 1 Year

  6. Electrophysiologic modifications

    Time frame: 1 Year

    Electrophysiological changes checked are QTc interval, documentation of arrhythmias

  7. Serum level of catecholamines

    Time frame: 1 year

  8. Serum level of plasma renin activity

    Time frame: 1 Year

Sponsors and collaborators

Lead sponsor

Institute of Liver and Biliary Sciences, India

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 19, 2014
Registry last updated
Feb 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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