Investigating heart problems in patients with fatty liver disease
Cirrhotic Cardiomyopathy and Cardiac Dysfunction in Patients with Metabolic Dysfunction Associated Steatotic Liver Disease
This study looks at how fatty liver disease might affect heart health in adults aged 18-65 by checking for heart problems like coronary artery disease and heart failure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Post Graduate Institute of Medical Education and Research, Chandigarh Academic / other |
| Locations | 1 site (Chandigarh, Chandigarh) |
| Trial ID | NCT06386094 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between non-alcoholic fatty liver disease (NAFLD) and cardiac dysfunction, particularly focusing on cirrhotic cardiomyopathy. Patients aged 18-65 with a diagnosis of metabolic dysfunction-associated steatotic liver disease will undergo echocardiographic assessments to evaluate the presence of coronary artery disease, arrhythmias, and heart failure. The study seeks to develop a model that links these cardiac issues to the underlying liver condition, addressing a gap in current research regarding the cardiovascular risks associated with NAFLD.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 diagnosed with metabolic dysfunction-associated steatotic liver disease.
Not a fit: Patients over 65 years old or those with significant cardiac or renal comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of cardiac dysfunction in patients with fatty liver disease, potentially reducing cardiovascular mortality.
How similar studies have performed: While there is emerging research linking NAFLD to cardiac dysfunction, this specific approach to model the relationship is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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). Exclusion Criteria: * Age \>65 years * Chronic renal disease * Pregnancy and peripartum cardiomyopathy * Hypertension * 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 at the time of assessment
Where this trial is running
Chandigarh, Chandigarh
- Dr. Madhumita Premkumar — Chandigarh, Chandigarh, India (Recruiting)
Study contacts
- Study coordinator: Madhumita Premkumar
- Email: drmadhumitap@gmail.com
- Phone: 01722754777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.