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

Recruiting now

Conditions studied: CKD - Chronic Kidney Disease, Heart Failure Preserved Ejection Fraction, SGLT2 Inhibitors, Diabetes (DM)

In brief

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.

Key facts

Study ID

NCT07237451

Run by

Grigore T. Popa University of Medicine and Pharmacy

People needed

200

Starts

2025-01-08

Expected to finish

2027-12-31

Last updated by the study team

2025-11-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

• Dr. C.I. Parhon Hospital in Iasi — Iași, Romania (enrolling)

Full record on ClinicalTrials.gov

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