Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-01-01 @ 3:24 PM
Study NCT ID:
NCT06426368
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Soluble ST2 in Patients With Heart Failure"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-17', 'studyFirstSubmitDate': '2024-05-12', 'studyFirstSubmitQcDate': '2024-05-17', 'lastUpdatePostDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate if Soluble ST2 is strongly associated with measures of HF severity and poor outcome', 'timeFrame': 'Baseline', 'description': 'Study ST2 level in heart failure patients and correlate results with clinical data and other inflammatory biomarker'}, {'measure': 'Evaluation of BNP and ST2 could have a potential role in prognosis.', 'timeFrame': 'Baseline', 'description': 'Study value of BNP in prognosis and compare it with ST2'}], 'secondaryOutcomes': [{'measure': '• Clinical Impact and Treatment Decision Support', 'timeFrame': 'Baseline', 'description': 'Evaluate ST2 as a novel biomarker which provide risk stratification of patients with acute and chronic HF beyond BNPs'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Heart Failure Patients']}, 'referencesModule': {'references': [{'pmid': '11418557', 'type': 'BACKGROUND', 'citation': 'Purdy GE, Payne SM. The SHI-3 iron transport island of Shigella boydii 0-1392 carries the genes for aerobactin synthesis and transport. J Bacteriol. 2001 Jul;183(14):4176-82. doi: 10.1128/JB.183.14.4176-4182.2001.'}]}, 'descriptionModule': {'briefSummary': '1. The aim of this study was to explore the relationship between peripheral circulating serum soluble suppression of tumorigenicity-2 (sST2) levels and inflammatory biomarkers in patients with heart failure\n2. Additive role of sST2 to NPs in of heart failure patients', 'detailedDescription': 'Heart failure (HF), a complex and heterogeneous medical syndrome characterized by structural and functional cardiac abnormalities and hemodynamic disruptions, represents the end-stage manifestation of numerous cardiovascular disorders . HF is categorized into three groups based on the measurement of the left ventricular (LV) ejection fraction (LVEF) according to the European Society of Cardiology (ESC) Guidelines issued in 2021: HF with reduced ejection fraction (HFrEF, LVEF ≤ 40%), HF with mildly reduced ejection fraction (HFmrEF, LVEF 41-49%), and HF with preserved ejection fraction (HFpEF, LVEF ≥ 50%) .\n\nQuantifying concentrations of circulating biomarkers plays a major role in most cardiovascular (CV) diseases, including (HF) .\n\nAn ideal biomarker in HF should be measured non-invasively and at low cost, highly sensitive to allow for the early detection of the disease .\n\nN-terminal pro-B-type natriuretic peptide (NT-proBNP) released by cardiac muscle tissue in response to abnormal volume load is an established indicator for the diagnosis and prognosis of HF .\n\nHowever, there are important limitations to natriuretic peptide (NP) testing in HF .\n\nSoluble suppression of tumorigenicity-2 (sST2) is the circulating form of the interleukin-33 membrane receptor released in response to inflammation, fibrosis in various organs, and myocardium stress .\n\nSoluble (s)ST2 has been proposed as a useful biomarker for heart failure (HF) patient management. Myocardial damage or mechanical stress stimulate sST2 release. ST2 competes with a membrane bound receptor (ST2 ligand, or ST2L) for interleukin-33 (IL-33) binding, inhibiting the effects induced by the ST2L/IL-33 interaction so that excessive sST2 may contribute to myocardial fibrosis and ventricular remodelling.\n\nSo biomarkers such as NT-proBNP and sST2 could potentially be used as surrogates for clinical outcomes in patients with HF and may be useful in monitoring disease progression and assessing the response to therapy .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will be conducted at Chemistry unit of Clinical Pathology Department and Cardiovascular Department, Assiut University Hospitals, Assiut University, Egypt Heart failure patients will be classified according to NYHA classification', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients 18-80 years.\n* Both sexes will be included.\n* including signs and symptoms of HF (e.g., elevated jugular venous pressure and altered apical beat position), altered LVEF (\\< 40%; 40%-49%; ≥ 50%)\n\nExclusion Criteria:\n\n* Patients \\<18 years\n* Patients with documented evidence of cardiogenic shock .\n* Patients with Acute coronary syndrome within 30 days.\n* chronic kidney disease patients with glomerular filtration rate \\< 30\n* Patients with interstitial pulmonary fibrosis .'}, 'identificationModule': {'nctId': 'NCT06426368', 'briefTitle': 'Soluble ST2 in Patients With Heart Failure"', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': '" Prognostic Value of Soluble ST2 Beyond B-Type Natriuretic Peptide in Management of Patients With Heart Failure"', 'orgStudyIdInfo': {'id': 'ST2 in H.F patients'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group I', 'description': 'HF with reduced ejection fraction (HFrEF, LVEF ≤ 40%)', 'interventionNames': ['Diagnostic Test: ST2']}, {'label': 'Group II', 'description': 'HF with mildly reduced ejection fraction (HFmrEF, LVEF 41-49%)', 'interventionNames': ['Diagnostic Test: ST2']}, {'label': 'Group III', 'description': 'HF with preserved ejection fraction (HFpEF, LVEF ≥ 50%)', 'interventionNames': ['Diagnostic Test: ST2']}], 'interventions': [{'name': 'ST2', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['BNP'], 'description': 'ELISA used to detect levels of ST2 and BNP as inflammatory biomarkers in patients with heart failure', 'armGroupLabels': ['Group I', 'Group II', 'Group III']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Dalia Hesham', 'role': 'CONTACT', 'email': 'daliahesham1771993@gmail.com', 'phone': '01149936172'}, {'name': 'randa ahmed', 'role': 'CONTACT', 'phone': '01003390690'}], 'overallOfficials': [{'name': 'Randa Ahmed', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}, {'name': 'Hanan Omer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}, {'name': 'Yousra Mamdouh', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'doctor', 'investigatorFullName': 'Dalia Mohamed Hesham Ahmed Mohamed', 'investigatorAffiliation': 'Assiut University'}}}}