Assessing heart function in patients with cirrhosis using echocardiography and biomarkers
Diagnosis and Pathogenetic Mechanisms in Cirrhotic Cardiomyopathy Based on Point-of-care Echocardiography, Biomarkers and Histology
This study is testing how well heart function is working in patients with cirrhosis to help improve their care and outcomes.
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 (Sector-12, Chandigarh) |
| Trial ID | NCT06095466 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with cirrhotic cardiomyopathy, a condition that increases the risk of severe complications such as hepatorenal syndrome and heart failure. The researchers will screen critically ill patients admitted to the Liver Intensive Care Unit using point-of-care echocardiography, electrocardiography, and biomarker tests to evaluate cardiac function and outcomes. In cases where patients do not survive, cardiac histology will be analyzed through ultrasound-guided myocardial biopsy to assess inflammation and fibrosis. The study aims to better understand the cardiac implications of cirrhosis and improve patient management.
Who should consider this trial
Good fit: Ideal candidates are critically ill patients aged 18-65 with a diagnosis of cirrhosis admitted to the Liver Intensive Care Unit.
Not a fit: Patients over 65 years old, those with chronic renal disease, or other specified exclusions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and management of cardiac dysfunction in patients with cirrhosis, potentially reducing morbidity and mortality.
How similar studies have performed: While there have been studies on cirrhotic cardiomyopathy, this specific approach using point-of-care echocardiography and histological assessment is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with cirrhosis who have been diagnosed by clinical, biochemical, histological (when available) criteria plus ultrasound imaging will be included if they meet the following: * Age range of 18-65 years * Cirrhosis with critical illness admitted to the Liver Intensive Care Unit Exclusion Criteria: * Age \>65 years * Chronic renal disease * Pregnancy and peripartum cardiomyopathy * Valvular heart disease * Sick sinus syndrome/ Pacemaker * 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
Sector-12, Chandigarh
- Dr. Madhumita Premkumar — Sector-12, 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.