MedTrace Logo

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

NCT07237451 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-11-19

No results posted yet for this study

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.

Conditions

  • CKD - Chronic Kidney Disease
  • Heart Failure Preserved Ejection Fraction
  • SGLT2 Inhibitors
  • Diabetes (DM)

Interventions

DIAGNOSTIC_TEST

Arterial 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_TEST

Echocardiography

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).

OTHER

Biomarkers determination

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

OTHER

NMR 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.

Sponsors & Collaborators

  • Dr. C.I. Parhon Hospital, Iasi

    collaborator UNKNOWN

  • The Executive Agency for Higher Education, Research, Development and Innovation Funding

    collaborator OTHER

  • Grigore T. Popa University of Medicine and Pharmacy

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-08
Primary Completion
2027-03-01
Completion
2027-12-31

Countries

  • Romania

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07237451 on ClinicalTrials.gov