About this trial
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
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Arterial stiffness
- Echocardiography
- Biomarkers determination
- NMR metabolomics and uremic toxins mapping
Treatment groups
Sponsors and collaborators
Grigore T. Popa University of Medicine and Pharmacy
Lead sponsor
Dr. C.I. Parhon Hospital, Iasi
Collaborator
The Executive Agency for Higher Education, Research, Development and Innovation Funding
Collaborator