Actively Recruiting
Cardiovascular and Renal Endpoints With Flozins - an Observational Prospective Study in CKD HFpEF Patients
Led by Grigore T. Popa University of Medicine and Pharmacy · Updated on 2025-11-19
200
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
Sponsors
G
Grigore T. Popa University of Medicine and Pharmacy
Lead Sponsor
D
Dr. C.I. Parhon Hospital, Iasi
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to comprehensively evaluate cardiovascular and kidney outcomes in patients with chronic kidney disease (CKD) and heart failure with preserved ejection fraction (HFpEF). It focuses on how SGLT2 inhibitor therapy affects endothelial function, major adverse cardiovascular events (MACE), and mortality. Researchers will use a variety of clinical evaluations, imaging techniques, blood tests, and novel biomarkers to study these effects. The study observes two groups of patients: those with CKD and HFpEF receiving SGLT2 inhibitor therapy and those not receiving this therapy. They will be assessed using arterial stiffness measurements by tonometry, echocardiography to examine heart structure and function, blood tests for biomarkers, and metabolomics profiling. These assessments will help understand cardiovascular and renal outcomes over time. Participants will undergo evaluations including flow-mediated dilatation, pulse wave velocity, intima-media thickness measurements, echocardiograms, and blood sampling for biomarker and metabolomics analysis. Researchers will monitor outcomes such as MACE and mortality over 10 to 20 months, as well as kidney function decline. This observational study is designed to gather detailed health information without altering participants’ treatments, lasting up to nearly three years from the start date.
CONDITIONS
Brief Title
Cardiovascular and Renal Endpoints With Flozins - an Observational Prospective Study in CKD HFpEF Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Ejection fraction above 40%
- Diagnosis of chronic kidney disease stage 3 or 4 with eGFR between 15 and 60 mL/min/1.73m2
- Patients with and without SGLT2 inhibitor therapy, including diabetic and non-diabetic individuals
- Age, sex, and CKD stage matched patients without SGLT2 inhibitor treatment
You will not qualify if you...
- eGFR below 15 mL/min/1.73m2 or patients undergoing dialysis
- Presence of congenital heart disease
- Decompensated liver cirrhosis
- Pregnancy
- Active malignancies
- Coronary artery disease, including history of acute coronary syndrome or significant coronary artery lesions
- Presence of cardiac medical devices such as metallic joint prostheses, cardiac stents, or pacemakers
- Active systemic infections that could affect biomarker results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline
Participants undergo various diagnostic assessments including arterial stiffness measurement, echocardiography, and biomarker determinations to evaluate cardiovascular and renal status.
1 baseline visit (in-person)
Duration - Up to 20 months
Participants are observed prospectively to assess cardiovascular and renal outcomes with or without SGLT2 inhibitor therapy through clinical evaluations and laboratory assessments.
Follow-up visits over 20 months
Trial Site Locations
Total: 1 location
1
Dr. C.I. Parhon Hospital in Iasi
Iași, Romania
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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