Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-25 @ 9:51 PM
Study NCT ID:
NCT07237451
Status:
RECRUITING
Last Update Posted:
2025-11-19
First Post:
2025-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cardiovascular and Renal Endpoints With Flozins - an Observational Prospective Study in CKD HFpEF Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D054144', 'term': 'Heart Failure, Diastolic'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059289', 'term': 'Vascular Stiffness'}, {'id': 'D004452', 'term': 'Echocardiography'}], 'ancestors': [{'id': 'D002320', 'term': 'Cardiovascular Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}, {'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-16', 'studyFirstSubmitDate': '2025-11-13', 'studyFirstSubmitQcDate': '2025-11-16', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Changes in cardiac biomarkers', 'timeFrame': 'Baseline, 10 and 20 months', 'description': 'Blood levels of NT-pro BNP, Syndecan-1, VCAM-1, Endoglin, NO and ADMA will be measured at baseline and months 10 and 20. The outcome is defined as the change from baseline.'}, {'measure': 'Changes in the NMR metabolomics and uremic toxins mapping', 'timeFrame': 'Baseline, 10 and 20 months', 'description': 'Blood levels of NMR metabolomics and uremic toxins will be measured at baseline and months 10 and 20. The outcome is defined as the change from baseline.'}], 'primaryOutcomes': [{'measure': 'MACE', 'timeFrame': '20 months', 'description': 'Composite CV outcome: time to first non-fatal myocardial infarction, non-fatal stroke, and hospitalization for heart failure or CV death'}, {'measure': 'All-cause mortality', 'timeFrame': '10 and 20 months', 'description': 'All-cause mortality'}], 'secondaryOutcomes': [{'measure': 'Composite renal outcome', 'timeFrame': '10 and 20 months', 'description': 'Rapid progression of renal disease - defined as sustained annual decline of at least 5mL/min/1,73m2 in eGFR or a sustained drop of 25% or more in eGFR within 10 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CKD', 'HFpEF', 'SGTL2 inhibitors', 'Biomarkers', 'PWV'], 'conditions': ['CKD - Chronic Kidney Disease', 'Heart Failure Preserved Ejection Fraction', 'SGLT2 Inhibitors', 'Diabetes (DM)']}, 'descriptionModule': {'briefSummary': 'The main aim of this study is to holistically assess the cardiovascular and renal outcomes in HFpEF CKD patients with and without SGLT2 inhibition, with focus on the endothelial disfunction, MACE and mortality using clinical evaluation, flow mediated dilatation, carotid-femoral pulse wave velocity, intima-media thickness, echocardiographic parameters, NMR metabolomics and a series of novel biomarkers.', 'detailedDescription': 'Chronic kidney disease (CKD) is considered to become the 5th cause of death worldwide by 2040. Aging populations, growing frequency of type 2 diabetes, hypertension, a low detection rate and therapeutic inertia in the early stages of CKD determined the increasing incidence and prevalence. CKD patients exhibit an elevated cardiovascular risk manifesting myocardial infarction and stroke, coronary artery disease, heart failure (HF), arrhythmias, and sudden cardiac death. The relationship between HF and CKD is bidirectional, with chronic HF promoting CKD development (cardio-renal syndrome type 1), and CKD promoting the development of HF (type 3). In the last decade, HF with preserved ejection fraction (HFpEF) represents the typical phenotype in patients with CKD, accounting for more than half of the cases of HF. Given the high burden of both HF and CKD, their complex interaction and challenging management, along with the prognostic implications regarding comorbidity and mortality, a comprehensive approach in the HFpEF population is mandatory, since HF diagnosis was evasive for years. The main aim of this study is to holistically assess the cardiovascular and renal outcomes in HFpEF CKD patients with and without SGLT2 inhibition, with focus on the endothelial disfunction, MACE and mortality using clinical evaluation, flow mediated dilatation, carotid-femoral pulse wave velocity, intima-media thickness, echocardiographic parameters, NMR metabolomics and a series of novel biomarkers.\n\nThe objectives of this prospective observational study are to determine:\n\n* the feasibility of PWV measurement and ventricular strain in HFpEF CKD patients with and without SGLT2 inhibition;\n* the cardiovascular outcomes, namely MACE, defined as time to first non-fatal myocardial infarction, non-fatal stroke, hospitalization for heart failure or CV death and on all-cause mortality in HFpEF CKD patients with and without SGLT2 inhibition;\n* the renal outcomes, such as rapid progression of renal disease - defined as sustained annual decline of at least 5mL/min/1,73m2 in eGFR or a sustained drop of 25% or more in eGFR within 12 months;\n* the metabolomics profile related to uremic toxins panel determined by NMR spectroscopy and other biological markers as novel molecules with a higher potential accuracy of predicting further major cardiovascular events in HFpEF CKD patients with and without SGLT2 inhibition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with CKD stages 3 and 4 (eGFR calculated by CKD-EPI) with HFpEF', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age\\>18 years;\n* ejection fraction \\> 40;\n* patients with CKD stage 3-4 (eGFR between 15-60 mL/min/1.73m2), with iSGLT2 recommendation, diabetic and non-diabetic;\n* age, sex and CKD stage 3 and 4 matched patients without iSGLT2 administration.\n\nExclusion Criteria:\n\n* eGFR\\< 15 mL/min/1.73m2 or patients undergoing dialysis;\n* presence of congenital heart disease, decompensated cirrhosis, pregnancy and active malignancies;\n* coronary artery disease (including those with a history of acute coronary syndrome, angina pectoris, or prior coronary angiography or CT angiography demonstrating significant coronary artery lesions);\n* cardiac medical devices, namely metallic joint prostheses, cardiac stent or pacemakers;\n* active systemic infections (due to interference with biomarkers that can give false rise values).'}, 'identificationModule': {'nctId': 'NCT07237451', 'acronym': 'CARE FOR CKD H', 'briefTitle': 'Cardiovascular and Renal Endpoints With Flozins - an Observational Prospective Study in CKD HFpEF Patients', 'organization': {'class': 'OTHER', 'fullName': 'Grigore T. Popa University of Medicine and Pharmacy'}, 'officialTitle': 'Cardiovascular and Renal Endpoints With Flozins - an Observational Prospective Study in CKD HFpEF Patients', 'orgStudyIdInfo': {'id': 'CARE FOR CKD HFPEF'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'iSGLT2 therapy', 'description': 'CKD and HFpEF with iSGLT2 therapy', 'interventionNames': ['Diagnostic Test: Arterial stiffness', 'Diagnostic Test: Echocardiography', 'Other: Biomarkers determination', 'Other: NMR metabolomics and uremic toxins mapping']}, {'label': 'Control', 'description': 'CKD and HFpEF without iSGLT2 therapy', 'interventionNames': ['Diagnostic Test: Arterial stiffness', 'Diagnostic Test: Echocardiography', 'Other: Biomarkers determination', 'Other: NMR metabolomics and uremic toxins mapping']}], 'interventions': [{'name': 'Arterial stiffness', 'type': 'DIAGNOSTIC_TEST', 'description': 'Arterial stiffness assessment will be performed by applanation tonometry with the patient being recumbent, 10 minutes before the measures were done. The carotid and femoral pulse will be acquired by applanation tonometry sequentially, allowing a single operator to acquire the measurement. The transit time from the R-wave of the simultaneously acquired electrocardiogram to the foot of the carotid and femoral pulse is measured. The difference acquired electrocardiogram to the foot of the carotid and femoral pulse is measured. The difference between these 2 transit times is divided by distances measured from the body surface to estimate the arterial path length in order to calculate carotid-femoral PWV.', 'armGroupLabels': ['Control', 'iSGLT2 therapy']}, {'name': 'Echocardiography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Echocardiography will be performed on each patient at baseline; the measurements will be carried out according to the recommendations of the American Society of Echocardiography. Echocardiographic evaluation will provide information about cardiac anatomy (e.g. volumes, geometry, mass) and function (e.g. left ventricular function and wall motion, valvular function, right ventricular function, pulmonary artery pressure, pericardium).', 'armGroupLabels': ['Control', 'iSGLT2 therapy']}, {'name': 'Biomarkers determination', 'type': 'OTHER', 'description': 'NT-pro BNP, Syndecan-1, VCAM-1, Endoglin, NO and ADMA will be determined by specific enzyme linked immunosorbent assay (ELISA) kits.', 'armGroupLabels': ['Control', 'iSGLT2 therapy']}, {'name': 'NMR metabolomics and uremic toxins mapping', 'type': 'OTHER', 'description': 'The aliquoted serum preserved at -80° C will be analysed by NMR using deuterated solvents (D2O, CDCl3, CD3OD, CD3CN), standards of metabolites and uremic toxins.', 'armGroupLabels': ['Control', 'iSGLT2 therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Iași', 'status': 'RECRUITING', 'country': 'Romania', 'contacts': [{'name': 'Adrian Covic C Head of Nephrology Clinic, MD, PhD', 'role': 'CONTACT', 'email': 'adrian.covic@umfiasi.ro', 'phone': '+40232211818'}, {'name': 'Gianina Dodi Researcher, PhD', 'role': 'CONTACT', 'email': 'gianina.dodi@umfiasi.ro', 'phone': '+40232211818'}, {'name': 'Adrian Covic, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Anca Stefan, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alexandra Covic, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Gianina Dodi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dr. C.I. Parhon Hospital in Iasi', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Grigore T. Popa University of Medicine and Pharmacy', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dr. C.I. Parhon Hospital, Iasi', 'class': 'UNKNOWN'}, {'name': 'The Executive Agency for Higher Education, Research, Development and Innovation Funding', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Adrian Covic', 'investigatorAffiliation': 'Grigore T. Popa University of Medicine and Pharmacy'}}}}