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Recruiting NCT07237451

Cardiovascular and Renal Endpoints With Flozins - an Observational Prospective Study in CKD HFpEF Patients

Trial Parameters

Condition CKD - Chronic Kidney Disease
Sponsor Grigore T. Popa University of Medicine and Pharmacy
Study Type OBSERVATIONAL
Phase N/A
Enrollment 200
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-01-08
Completion 2027-03-01
Interventions
Arterial stiffnessEchocardiographyBiomarkers determination

Brief 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 Criteria

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).

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