Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-27 @ 4:49 AM
Study NCT ID:
NCT06284850
Status:
RECRUITING
Last Update Posted:
2024-02-29
First Post:
2024-01-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Empagliflozin and Red Blood Cell 2,3-biphosphoglycerate Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C570240', 'term': 'empagliflozin'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-27', 'studyFirstSubmitDate': '2024-01-10', 'studyFirstSubmitQcDate': '2024-02-27', 'lastUpdatePostDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change in red blood cell 2,3-biphosphoglycerate levels (μmol/ml)', 'timeFrame': '12 weeks', 'description': 'Mean change in red blood cell 2,3-biphosphoglycerate levels (μmol/ml)'}], 'secondaryOutcomes': [{'measure': 'Mean change in Hct (%)', 'timeFrame': '12 weeks', 'description': 'Mean change in Hct(%)'}, {'measure': 'Hb (mg/dl)', 'timeFrame': '12 weeks', 'description': 'Mean change in Hb (mg/dl)'}, {'measure': 'RBC (x1000000/μl)', 'timeFrame': '12 weeks', 'description': 'Mean change in RBC (x1000000/μl)'}, {'measure': 'MCV (fl),', 'timeFrame': '12 weeks', 'description': 'Mean change in MCV (fl)'}, {'measure': 'HbA1c (%, mmol/mol),', 'timeFrame': '12 weeks', 'description': 'Mean change inHbA1c (%, mmol/mol)'}, {'measure': 'erythropoietin (mU/ml)', 'timeFrame': '12 weeks', 'description': 'Mean change in erythropoietin (mU/ml)'}, {'measure': 'eGFR (ml/min/1.73m2),', 'timeFrame': '12 weeks', 'description': 'Mean change in eGFR (ml/min/1.73m2),'}, {'measure': 'Urine Albumin to Creatinine Ratio (mg/g)', 'timeFrame': '12 weeks', 'description': 'Mean change in Urine Albumin to Creatinine Ratio (mg/g)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hematocrit Change', 'Cardiovascular Prevention', 'Empagliflozin', 'SGLT2-Inhibitors', 'Tissue Oxygenation']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the hypothesis that treatment with empagliflozin may have an impact on red blood cell 2,3-biphosphoglycerate levels affecting tissue oxygen supply and thus mediating part of the cardio- and reno- protective effect of SGLT-2 inhibitors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients\\>18 year-old and at least one of the following\n\n* Type 2 Diabetes Mellitus and HbA1c: 6.5-9.0% or HbA1c \\<6.5% and history of Coronary Artery Disease or Stroke not treated with GLP-1RA\n* Heart Failure defined as Ejection Fraction\\<40% or NT-proBNP\\>300pg/ml or Atrial fibrillation and NT-proBNP\\>900pg/ml\n* Chronic Kidney Disease defined as eGFR\\<60ml/min/1.73m2 (CKPD- EPI) or/and UACR\\>200mg/g Initiating treatment with empagliflozin 10mg once daily as add on treatment', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients\\>18 year-old and at least one of the following\n\n* Type 2 Diabetes Mellitus and HbA1c: 6.5-9.0% or HbA1c \\<6.5% and history of Coronary Artery Disease or Stroke not treated with GLP-1RA\n* Heart Failure defined as Ejection Fraction\\<40% or NT-proBNP\\>300pg/ml or Atrial fibrillation and NT-proBNP\\>900pg/ml\n* Chronic Kidney Disease defined as eGFR\\<60ml/min/1.73m2 (CKPD- EPI) or/and UACR\\>200mg/g Initiating treatment with empagliflozin 10mg once daily as add on treatment\n\nExclusion Criteria:\n\n* Patients already treated with an SGLT-2 inhibitor\n* Patients with Hb\\<11gr/dl or\\>16gr/dl\n* Patients with history of inherited or acquired hemoglobin disease\n* Patients with history of hemolytic anemia\n* Patients with history of hematologic malignancy or myelodysplastic syndrome or myeloproliferative syndrome\n* Patients treated within the last 6 months for anemia due to iron, B12 or folate deficiency\n* Patients with history of major hemorrhage or major operation leading to RBC transfusion within the last 3 months.\n* Patients planning major operation or revascularization procedure within the 12 following weeks\n* Patients treated with erythropoietin\n* Patients with Chronic Kidney Disease and GFR\\<30ml/min/1.73m2\n* Pregnancy\n* Women of childbearing age not receiving appropriate contraception measures'}, 'identificationModule': {'nctId': 'NCT06284850', 'briefTitle': 'Empagliflozin and Red Blood Cell 2,3-biphosphoglycerate Levels', 'organization': {'class': 'OTHER', 'fullName': 'Aristotle University Of Thessaloniki'}, 'officialTitle': 'Red Blood Cell 2,3-biphosphoglycerate Levels in Patients Treated With Empagliflozin. A Prospective Cohort Study.', 'orgStudyIdInfo': {'id': 'Christina Trakatelli'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'treatment with empagliflozin 10mg od', 'description': 'empagliflozin 10mg OD', 'interventionNames': ['Drug: Empagliflozin10Mg Tab']}], 'interventions': [{'name': 'Empagliflozin10Mg Tab', 'type': 'DRUG', 'otherNames': ['JARDIANCE 10MG'], 'description': 'TB JARDIANCE 10MG', 'armGroupLabels': ['treatment with empagliflozin 10mg od']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56403', 'city': 'Thessaloniki', 'state': 'Central Macedonia', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'KONSTANTINOS KITSIOS, MD,MSc,PhD', 'role': 'CONTACT', 'email': 'kitsios_k@yahoo.gr', 'phone': '+306977295744'}], 'facility': 'Papageorgiou General Hospital', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}], 'centralContacts': [{'name': 'KONSTANTINOS KITSIOS, MD,MSc,PhD', 'role': 'CONTACT', 'email': 'kitsios_k@yahoo.gr', 'phone': '+306977295744'}], 'overallOfficials': [{'name': 'KONSTANTINOS KITSIOS, MD,MSc,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aristotle University of Thessaloniki 3d Department of Internal Medicine, Papageorgiou General Hospital, Thessaloniki, Greece'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'concerns about personal data safety'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aristotle University Of Thessaloniki', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor Of Internal Medicine', 'investigatorFullName': 'Christina Trakatelli', 'investigatorAffiliation': 'Aristotle University Of Thessaloniki'}}}}