Cardiovascular and Renal Endpoints With Flozins - an Observational Prospective Study in CKD HFpEF Patients
Grigore T. Popa University of Medicine and Pharmacy
200 participants
Jan 8, 2025
OBSERVATIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria5
- 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).
Interventions
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.
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).
NT-pro BNP, Syndecan-1, VCAM-1, Endoglin, NO and ADMA will be determined by specific enzyme linked immunosorbent assay (ELISA) kits.
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.
Locations(1)
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NCT07237451