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Cardiovascular and Renal Endpoints With Flozins - an Observational Prospective Study in CKD HFpEF Patients
RECRUITINGSponsored by Grigore T. Popa University of Medicine and Pharmacy
Actively Recruiting
SponsorGrigore T. Popa University of Medicine and Pharmacy
Started2025-01-08
Est. completion2027-03-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07237451
Summary
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.
Eligibility
Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria: * age\>18 years; * ejection fraction \> 40; * patients with CKD stage 3-4 (eGFR between 15-60 mL/min/1.73m2), with iSGLT2 recommendation, diabetic and non-diabetic; * age, sex and CKD stage 3 and 4 matched patients without iSGLT2 administration. Exclusion Criteria: * eGFR\< 15 mL/min/1.73m2 or patients undergoing dialysis; * presence of congenital heart disease, decompensated cirrhosis, pregnancy and active malignancies; * 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); * cardiac medical devices, namely metallic joint prostheses, cardiac stent or pacemakers; * active systemic infections (due to interference with biomarkers that can give false rise values).
Conditions6
CKD - Chronic Kidney DiseaseDiabetesDiabetes (DM)Heart DiseaseHeart Failure Preserved Ejection FractionSGLT2-Inhibitors
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Actively Recruiting
SponsorGrigore T. Popa University of Medicine and Pharmacy
Started2025-01-08
Est. completion2027-03-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07237451