Cardiovascular and Renal Endpoints With Flozins - an Observational Prospective Study in CKD HFpEF Patients
Recruiting · NCT07237451 · Observational (researchers observe without assigning treatment) · Lead sponsor: Grigore T. Popa University of Medicine and Pharmacy
View the official record on ClinicalTrials.gov →Interventions studied
Arterial stiffnessBiomarkers determinationEchocardiographyNMR metabolomics and uremic toxins mapping
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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).
Where it is running
1 location listed.
- Dr. C.I. Parhon Hospital in Iasi - Iași, Romania