RecruitingNCT07237451

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

Sponsor

Grigore T. Popa University of Medicine and Pharmacy

Enrollment

200 participants

Start Date

Jan 8, 2025

Study Type

OBSERVATIONAL

Conditions

CKD - Chronic Kidney Disease Heart Failure Preserved Ejection Fraction

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This observational study is tracking heart and kidney health outcomes in people with chronic kidney disease (CKD) and a type of heart failure (where the heart pumps normally but the muscle is stiff — called HFpEF) who are treated with a class of medications called SGLT2 inhibitors (flozins, such as dapagliflozin or empagliflozin), compared to those who are not. **You may be eligible if...** - You are over 18 years old - You have CKD stage 3 or 4 (moderately reduced kidney function) - You have heart failure with preserved ejection fraction (your heart pumps normally but is stiff) - You have been recommended SGLT2 inhibitor (flozin) therapy, whether or not you have diabetes, OR you are matched to someone who is **You may NOT be eligible if...** - Your kidney function is very severely reduced or you are on dialysis - You have congenital heart disease, active cancer, or decompensated liver disease - You are pregnant - You have coronary artery disease or a heart stent/pacemaker Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTArterial stiffness

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.

DIAGNOSTIC_TESTEchocardiography

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).

OTHERBiomarkers determination

NT-pro BNP, Syndecan-1, VCAM-1, Endoglin, NO and ADMA will be determined by specific enzyme linked immunosorbent assay (ELISA) kits.

OTHERNMR metabolomics and uremic toxins mapping

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.