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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGrigore T. Popa University of Medicine and Pharmacy

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

200 Participants
are divided into 2 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