Ignite Creation Date:
2025-12-24 @ 12:24 PM
Ignite Modification Date:
2026-01-03 @ 8:05 PM
Study NCT ID:
NCT06585761
Status:
RECRUITING
Last Update Posted:
2024-09-05
First Post:
2024-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Sodium Glucose Co-tansporter 2 Inhibitors (SGLT2I) on Inflammatory and Oxidative Stress Markers Level in Heart Failure Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077203', 'term': 'Sodium-Glucose Transporter 2 Inhibitors'}, {'id': 'C570240', 'term': 'empagliflozin'}, {'id': 'C529054', 'term': 'dapagliflozin'}], 'ancestors': [{'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D007004', 'term': 'Hypoglycemic Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum sample'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-03', 'studyFirstSubmitDate': '2024-08-23', 'studyFirstSubmitQcDate': '2024-09-03', 'lastUpdatePostDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'measure effect of SGLT2I ON serum concentration( level) of cardiac stress markers in heart failure patients before and after the intervention', 'timeFrame': '1 year', 'description': 'At follow up, patients will be clinically evaluated for the changes in serum levels of the studied biomarkers such as MDA which plasma concentration is measured in nM'}], 'primaryOutcomes': [{'measure': 'measure effect of SGLT2I ON serum concentration ( level) of cardiac biomarkers in heart failure patients before and after the intervention', 'timeFrame': '1 year', 'description': 'At follow up, patients will be clinically evaluated for the changes in serum levels of the studied biomarkers the studied biomarker is NT-proBNP, its concentration is measured in pg/mL.'}, {'measure': 'clinical examination for the presence and extent of improvement in signs and symptoms', 'timeFrame': '1 year', 'description': 'Clinical examination depending on NYHA classification of the participants'}], 'secondaryOutcomes': [{'measure': 'measure effect of SGLT2I ON serum concentration ( level) of cardiac inflammatory marker ( IL-6) in heart failure patients before and after the intervention', 'timeFrame': '1 year', 'description': 'At follow up, patients will be clinically evaluated for the changes in serum levels of the studied biomarker\n\nIl-6 serum concentration is measured in pg/mL'}, {'measure': 'Measure the effect of SGLT2I on serum concentration ( level) of cardiac inflammatory marker ( TNF-Alpha) in heart failure patients before and after the intervention', 'timeFrame': '1 year', 'description': 'TNF-Alpha serum concentration is measured in pg/ml'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to explore the effect of SGLT2i on the levels of cardiac biomarkers, inflammatory and stress markers in Egyptian heart failure patients to provide a better understanding of mechanism that might assist in tailoring treatment strategies in patients with various forms of HF especially in Egyptian population. Also understand how biomarkers may be employed to predict risk in patients receiving SGLT2i or identification of those who may derive the most benefit from SGLT2i in the means of individualized medicine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'participants who are candidates for SGLT2i and will be recruited from Cardiology Department, Kafrelshiekh University Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients aged more than 18 years old.\n2. Patients are with cardiac function was graded as II-IV by the New York Heart Association (NYHA)\n3. Patients are on standard therapy for management of HF (according to AHA/ACC/HFSA Guideline for the Management of Heart Failure2022)21 such as:\n\n * ACEi (angiotensin converting enzyme inhibitor)\n * ARB (angiotensin receptor blocker)\n * ARNI in place of ACEi OR ARB\n * Beta blocker\n * (MRA) Mineralocorticoid receptor antagonists\n * Diuretics as needed.\n4. All patients signed the informed consent.\n\nExclusion Criteria:\n\n1. Patients suffering from conditions like acute CVS illness and severe sepsis that raise inflammatory markers and may lead to cardiac dysfunction as opposed to heart failure.\n2. Patients with various cardiac conditions, such as severe congenital heart disease, myocarditis, and valvular heart disease.\n3. Female patients during pregnancy or lactation\n4. Individuals suffering from a malignant tumor, hyperfunctioning thyroid, multiple organ failure, or significantly reduced kidney function (eGFR \\<20 mL/min/1.73 m²).\n5. Individuals suffering from verbal communication disorders or psychic cognitive impairment.'}, 'identificationModule': {'nctId': 'NCT06585761', 'briefTitle': 'Effect of Sodium Glucose Co-tansporter 2 Inhibitors (SGLT2I) on Inflammatory and Oxidative Stress Markers Level in Heart Failure Patients', 'organization': {'class': 'OTHER', 'fullName': 'Kafrelsheikh University'}, 'officialTitle': 'Effect of Sodium Glucose Co-tansporter 2 Inhibitors (SGLT2I) on Inflammatory and Oxidative Stress Markers Level in Heart Failure Patients', 'orgStudyIdInfo': {'id': 'KFSIRB200-128'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'pre-SGLT2I group', 'description': 'patients with heart failure newly introduced to one of SGLT2I members', 'interventionNames': ['Device: echo cardiogram']}, {'label': 'Post-SGLT2I group', 'description': 'patients with heart failure on one of SGLT2I members for at least 2 months', 'interventionNames': ['Drug: SGLT2 inhibitor', 'Device: echo cardiogram']}], 'interventions': [{'name': 'SGLT2 inhibitor', 'type': 'DRUG', 'otherNames': ['empagliflozin, Dapagliflozin'], 'description': 'patients with HF are subjected to regular dose of SGLT2I member according to patient status.', 'armGroupLabels': ['Post-SGLT2I group']}, {'name': 'echo cardiogram', 'type': 'DEVICE', 'description': 'the patients are subjected to ECHO to determine their EF prior to and post the study', 'armGroupLabels': ['Post-SGLT2I group', 'pre-SGLT2I group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33516', 'city': 'Kafr ash Shaykh', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Nada Nabil Mohammed Elsalhey, Bsc', 'role': 'CONTACT', 'email': 'nada.nabil@pharm.kfs.edu.eg', 'phone': '01062787805'}], 'facility': 'Kafrelsheikh University Hospital', 'geoPoint': {'lat': 31.11174, 'lon': 30.93991}}], 'centralContacts': [{'name': 'Nada Nabil mohammed elsalhey, BSC', 'role': 'CONTACT', 'email': 'nada.nabil@pharm.kfs.edu.eg', 'phone': '+201062787805'}], 'overallOfficials': [{'name': 'Nada Nabil Mohammed Elsalhey, Bsc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'clinical pharmacy department, kafrelsheikh university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'not yet decided by participant'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kafrelsheikh University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Nada Nabil Elsalhey', 'investigatorAffiliation': 'Kafrelsheikh University'}}}}