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NCT06386094Recruiting

Cardiac Dysfunction in Patients with Fatty Liver Disease

Cirrhotic Cardiomyopathy and Cardiac Dysfunction in Patients with Metabolic Dysfunction Associated Steatotic Liver Disease

Source: ClinicalTrials.gov · Last updated 29 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Cirrhotic cardiomyopathy is seen as a blunted contractile responsiveness to stress, and/or altered diastolic relaxation with electrophysiological abnormalities, in absence of known cardiac disease. Left ventricular diastolic dysfunction (LVDD) is associated with risk of hepatorenal syndrome (HRS) , septic shock. , heart failure in the perioperative period following liver transplantation, and after trans-jugular intrahepatic portosystemic shunt (TIPS) insertion . The echocardiographic E/e' ratio is a predictor of survival in LVDD, with multiple studies, including prospective data from our Centre. The inability of the heart to cope with stress or sepsis induced circulatory failure is a key concept of the increased mortality risk due to LVDD. In view of the metabolic syndrome and diabetes epidemic and an increasing number of patients being diagnosed with non-alcoholic fatty liver disease, there is increased risk of developing cardiac dysfunction due to multiple comorbidities including coronary artery disease, hypertensive heart disease, cirrhotic cardiomyopathy, which are contributors to overall cardiovascular risk of mortality.

Status (registry)
Recruiting
Study type
Observational
Enrollment
150 (estimated)
First submitted
19 Sept 2023
Start date
15 Jul 2023
Primary completion date
15 Aug 2027
Lead sponsor
Post Graduate Institute of Medical Education and Research, Chandigarh
NCT number
NCT06386094

What you commit to

  • Study type: Observational
  • Planned participants: 150
  • From 15 Jul 2023 to the primary completion date, 15 Aug 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Chronic renal disease
  • Hypertension
  • Valvular heart disease
  • Sick sinus syndrome/ Pacemaker
  • Cardiac rhythm disorder
  • Portal vein thrombosis

Age

  • Age \>65 years

Other

  • Pregnancy and peripartum cardiomyopathy
  • Hypothyroidism
  • Hyperthyroidism
  • Transjugular intrahepatic porto systemic shunt (TIPS) insertion
  • Hepatocellular carcinoma
  • Anemia Hb \< 8gm/dl in females, and \< 9 gm/dl in males at the time of assessment

Who the study is looking for

  • Age range of 18-65 years
  • metabolic dysfunction associated steatotic liver disease as diagnosed either by histology or clinical, laboratory, non invasive tests, USG findings and vibration controlled transient elastography (VCTE).

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Dr. Madhumita Premkumar
Coordinator of this site? Confirm its status
ChandigarhIndiaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.