Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 2:00 AM
Study NCT ID:
NCT04764305
Status:
RECRUITING
Last Update Posted:
2024-03-13
First Post:
2021-02-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Liver Disease, Myocardial Fibrosis and Collaterals in the Adult Fontan Patient a Metabolomics and Proteomics Approach
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010358', 'term': 'Patient Participation'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-11', 'studyFirstSubmitDate': '2021-02-17', 'studyFirstSubmitQcDate': '2021-02-17', 'lastUpdatePostDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants', 'timeFrame': 'July 2021-December 2023', 'description': 'When aspired number of participants is reached'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fontan', 'congenital heart disease', 'inflammation', 'Fontan-associated liver disease', 'Myocardial fibrosis', 'Collateral vessel'], 'conditions': ['Patient Participation', 'Heart Defects, Congenital', 'Liver Diseases', 'Collateral Circulation, Any Site', 'Myocardial Fibrosis']}, 'descriptionModule': {'briefSummary': 'Out objective is to identify the mechanisms that promote hepatic and myocardial fibrosis, and collateral vessel formation in patients with complex congenital heart disease and Fontan circulation.', 'detailedDescription': "In their prior works the investigators could show that there is evidence of a proinflammatory condition in a certain subgroup of patients with complex congenital heart disease and a so called Fontan circulation. Those patients are also prone to develop hepatic and myocardial fibrosis as well as to reveal collateral vessel formation. The investigators' hypothesis is that this pro-inflammatory condition is not only reflecting pre-stages of one or more of those 3 issues, but that this is also a main driving mechanism to develop and hepatic or myocardial fibrosis and collateral vessels.\n\nThe objective of the here proposed study thus is to identify the mechanisms that promote hepatic and myocardial fibrosis, and collateral vessel formation, and thus provide insight into the determination of those Fontan patients that tend to develop those conditions. The investigators attempt to link the issues of hepatic and myocardial fibrosis and collateral vessel formation by directing our focus on the phospholipid, amino acid and bile acid metabolism and on cell surface markers, cytokines, and chemokines as surrogates for proinflammatory, profibrotic and proangiogenic conditions.\n\nThis study would thereby allow for a deeper insight into Fontan pathophysiology and sequelae and might provide first steps towards the identification of possible diagnostic or eventually therapeutic targets."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients with Fontan circulation, see inclusion criteria. Healthy, biventrucal age- and sex-matched controls.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* written informed consent of participants\n* age at testing of ≥18 years\n* 8 h fasting before blood sampling\n* Fontan circulation (patients)\n* biventricular heart without structural or functional abnormality (controls)\n\nExclusion Criteria:\n\n* Protein losing enteropathy (PLE) (patients are defined as "PLE positive" if there is/are serum protein \\<5g/dL and serum albumin \\<3g/dL (duration for more than 3 months and exclusion of other causes for hypoproteinemia) and documented enteric protein loss: faecal alpha-1-antitrypsin ≥400 µg/g\n* medication directly affecting metabolic state, such as cholesterol-lowering agents, or haemodynamic state, such as beta-blockers or sildenafil, with the exception of angiotensin converting enzyme inhibitors, diuretics, and anticoagulants\n* atrial or ventricular arrhythmia\n* coronary artery disease (history of myocardial infarction, myocardial revascularisation, percutaneous coronary intervention, or coronary artery bypass surgery)\n* any metabolic disease, such as diabetes mellitus\n* malignancy\n* obesity (body mass index (BMI) \\>25 kg/m2)\n* underweight (BMI \\< 18 kg/m2)\n* renal disease\n* inflammatory disease such as acute or chronic infection\n* myeloproliferative disorder\n* pregnancy or lactation\n* malnourishment\n* mental handicap not allowing valid consent to participation in the study or CMR\n* need of sedation or general anesthesia for CMR\n* typical contraindications for performing CMR such as metal-containing mechanical or electronic implants\n* claustrophobia'}, 'identificationModule': {'nctId': 'NCT04764305', 'briefTitle': 'Liver Disease, Myocardial Fibrosis and Collaterals in the Adult Fontan Patient a Metabolomics and Proteomics Approach', 'organization': {'class': 'OTHER', 'fullName': 'Medical University Innsbruck'}, 'officialTitle': 'Liver Disease, Myocardial Fibrosis and Collaterals in the Adult Fontan Patient - a Metabolomics and Proteomics Approach', 'orgStudyIdInfo': {'id': 'registration in progress'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Patients with Fontan circulation. No intervention planned (observational study)'}, {'label': 'Controls', 'description': 'Healthy, biventricular controls. No intervention planned (observational study)'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Innsbruck', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Miriam Michel', 'role': 'CONTACT', 'email': 'miriam.michel@i-med.ac.at', 'phone': '+436606862227'}, {'role': 'CONTACT', 'phone': '+436606862227'}], 'facility': 'Medical University of Innsbruck', 'geoPoint': {'lat': 47.26266, 'lon': 11.39454}}], 'centralContacts': [{'name': 'Maria-Miriam Michel, MD', 'role': 'CONTACT', 'email': 'miriam.michel@i-med.ac.at', 'phone': '+436606862227'}], 'overallOfficials': [{'name': 'Miriam Michel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Innsbruck'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University Innsbruck', 'class': 'OTHER'}, 'collaborators': [{'name': 'Heart and Diabetes Center North Rhine-Westphalia', 'class': 'OTHER'}, {'name': 'Austrian Science Fund (FWF)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'OÄ Dr. Miriam Michel', 'investigatorAffiliation': 'Medical University Innsbruck'}}}}