NCT06386094 Cardiac Dysfunction in Patients with Fatty Liver Disease
| NCT ID | NCT06386094 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Post Graduate Institute of Medical Education and Research, Chandigarh |
| Condition | NAFLD |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2023-07-15 |
| Primary Completion | 2027-08-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2023-07-15 with a primary completion date of 2027-08-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06386094 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying NAFLD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06386094 currently recruiting?
Yes, NCT06386094 is actively recruiting participants. Contact the research team at drmadhumitap@gmail.com for enrollment information.
Where is the NCT06386094 trial being conducted?
This trial is being conducted at Chandigarh, India.
Who is sponsoring the NCT06386094 clinical trial?
NCT06386094 is sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh. The trial plans to enroll 150 participants.