Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-27 @ 11:27 PM
Study NCT ID:
NCT06386094
Status:
RECRUITING
Last Update Posted:
2025-01-29
First Post:
2023-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Dysfunction in Patients with Fatty Liver Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum Sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-27', 'studyFirstSubmitDate': '2023-09-19', 'studyFirstSubmitQcDate': '2024-04-23', 'lastUpdatePostDateStruct': {'date': '2025-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the prevalence of cardiac dysfunction in patients with non-alcoholic fatty liver disease/ metabolic dysfunction associated steatotic liver disease', 'timeFrame': 'At Enrolment', 'description': 'Prevalence of CCM in the MASLD cohort'}], 'secondaryOutcomes': [{'measure': 'Presence of myocardial abnormalities in CCM dysfunction', 'timeFrame': 'At Enrolment', 'description': 'Use of cardiac MRI or CT'}, {'measure': 'Presence of perfusion abnormalities in CCM dysfunction', 'timeFrame': 'At Enrolment', 'description': 'Use of LV scintigraphy'}, {'measure': 'All cause mortality in metabolic dysfunction associated steatotic liver disease', 'timeFrame': '12 months after enrolment', 'description': 'All cause mortality will be recorded'}, {'measure': 'Cardiac event related mortality in MASLD', 'timeFrame': '12 months after enrolment', 'description': 'Cardiovascular events like incidence of arrhythmia, symptomatic heart failure related deaths will be recorded.'}, {'measure': 'To determine the severity of cardiac dysfunction in patients with metabolic dysfunction associated steatotic liver disease', 'timeFrame': 'At Enrolment', 'description': 'Prevalence of CCM in the MASLD cohort, and grade of LV diastolic and systolic dysfunction'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MASLD', 'Cirrhotic Cardiomyopathy', 'Heart failure in Cirrhosis', 'Coronary Artery Disease'], 'conditions': ['NAFLD', 'Cardiac Disease', 'Fatty Liver', 'MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease']}, 'referencesModule': {'references': [{'pmid': '26707365', 'type': 'BACKGROUND', 'citation': 'Younossi ZM, Koenig AB, Abdelatif D, Fazel Y, Henry L, Wymer M. Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology. 2016 Jul;64(1):73-84. doi: 10.1002/hep.28431. Epub 2016 Feb 22.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "Nonalcoholic fatty liver disease (NAFLD) and heart failure (HF) are obesity-related conditions with high cardiovascular mortality. Many new studies have linked NAFLD to changes in myocardial energy metabolism, and to echocardiographic measurements of cardiac dysfunction especially heart failure with preserved ejection fraction. Cardiac dysfunction in NAFLD is related to the release of inflammatory cytokines among those with steatohepatitis (NASH). However composite models looking at coronary artery disease, systolic and diastolic heart failure and outcomes in patients with NAFLD are limited, and the few preliminary analyses of this relationship using histologically-defined NASH or lean NAFLD remain unclear.\n\nIn this project the investigators will screen patients with a diagnosis of 'non-alcoholic fatty liver disease' for presence of coronary artery disease, arrhythmias, cirrhotic cardiomyopathy and develop a model for cardiac dysfunction in such patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The target population for this study is all patients with a diagnosis of metabolic dysfunction associated steatotic liver disease seen in the outpatient and inpatient services of the Department of Hepatology, PGIMER Chandigarh.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age range of 18-65 years\n* 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).\n\nExclusion Criteria:\n\n* Age \\>65 years\n* Chronic renal disease\n* Pregnancy and peripartum cardiomyopathy\n* Hypertension\n* Valvular heart disease\n* Sick sinus syndrome/ Pacemaker\n* Cardiac rhythm disorder\n* Hypothyroidism\n* Hyperthyroidism\n* Portal vein thrombosis\n* Transjugular intrahepatic porto systemic shunt (TIPS) insertion\n* Hepatocellular carcinoma\n* Anemia Hb \\< 8gm/dl in females, and \\< 9 gm/dl in males at the time of assessment'}, 'identificationModule': {'nctId': 'NCT06386094', 'briefTitle': 'Cardiac Dysfunction in Patients with Fatty Liver Disease', 'organization': {'class': 'OTHER', 'fullName': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}, 'officialTitle': 'Cirrhotic Cardiomyopathy and Cardiac Dysfunction in Patients with Metabolic Dysfunction Associated Steatotic Liver Disease', 'orgStudyIdInfo': {'id': 'INT/IEC/2023/SPL-902'}, 'secondaryIdInfos': [{'id': 'IEC/2024/1523 dt 3.12.2024', 'type': 'OTHER', 'domain': 'Postgraduate Institute of Medical Education and Research'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'MASLD', 'description': 'Non invasive tests like APRI, FIB-4, , FAST scan and VCTE in the form of Fibroscan will be done and recorded.\n\nLiver biopsy would be done as per the clinical indication. Diagnosis of NAFLD will be based on history, physical examination, laboratory investigations, upper gastrointestinal endoscopy, imaging studies (ultrasonography and Doppler of spleno portal venous axis, VCTE) and liver biopsy where available.', 'interventionNames': ['Diagnostic Test: Echocardiographic assessment']}], 'interventions': [{'name': 'Echocardiographic assessment', 'type': 'DIAGNOSTIC_TEST', 'description': 'M mode, cross sectional and pulsed wave Doppler Echocardiographic examinations will be performed using a with a 2.5 MHz wide angle phased array transducer. Patients will be laid in left lateral position and examined in standard parasternal long and short axis and apical views. Short axis recordings will be performed at the level of the papillary muscles. M mode tracings will be recorded at the level of the papillary muscles and the aortic valves, with 2 -D guidance. LV wall thickness and cavity diameters will be measured by M mode, through the largest diameter of the ventricle, if possible, both in diastole and systole. Using the cross-sectional images as a guide, the M mode tracing of the left ventricle will obtained to calculate measurements according to the recommendations of American Society of Echocardiography.', 'armGroupLabels': ['MASLD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '160012', 'city': 'Chandigarh', 'state': 'Chandigarh', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Dr. Madhumita Premkumar, MD', 'role': 'CONTACT', 'email': 'drmadhumitap@gmail.com', 'phone': '+9101722754777'}], 'facility': 'Dr. Madhumita Premkumar', 'geoPoint': {'lat': 30.73629, 'lon': 76.7884}}], 'centralContacts': [{'name': 'Madhumita Premkumar', 'role': 'CONTACT', 'email': 'drmadhumitap@gmail.com', 'phone': '01722754777'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Post Graduate Institute of Medical Education and Research, Chandigarh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Madhumita Premkumar', 'investigatorAffiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}}}}