Cardio-renal outcomes with SGLT2 inhibitors in CKD patients with HFpEF

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

This project will try to see if people with stage 3–4 CKD and HFpEF who take SGLT2 inhibitors have better heart and kidney outcomes than similar patients who do not.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Grigore T. Popa University of Medicine and Pharmacy (other)
• Locations: 1 site (Iași)
• Trial ID: NCT07237451 on ClinicalTrials.gov

What this trial studies

This prospective observational cohort will follow adults with stage 3–4 chronic kidney disease and heart failure with preserved ejection fraction who are matched by age, sex, and CKD stage and either taking or not taking SGLT2 inhibitors. Investigators will record clinical events including major adverse cardiovascular events and mortality and perform vascular and cardiac function testing such as flow-mediated dilation, carotid-femoral pulse wave velocity, intima-media thickness, and echocardiography. Participants will also undergo NMR metabolomics and a panel of novel biomarkers and uremic toxin mapping to explore biological mechanisms linking SGLT2 use to outcomes. Because therapy is not assigned, the design focuses on real-world associations and mechanistic insights rather than randomized causal inference.

Who should consider this trial

Good fit: Adults over 18 with stage 3–4 CKD (eGFR 15–60 mL/min/1.73 m2) and HFpEF (EF >40%), including both diabetic and non-diabetic patients, who are either taking an SGLT2 inhibitor or are matched nonusers.

Not a fit: People with end-stage kidney disease (eGFR <15 mL/min/1.73 m2) on dialysis, active malignancy, decompensated cirrhosis, congenital heart disease, recent significant coronary artery disease, implanted cardiac devices, pregnancy, or active infection are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the findings could help clarify whether SGLT2 inhibitors improve cardiovascular and renal outcomes and identify biomarkers that predict benefit in CKD patients with HFpEF.

How similar studies have performed: Large randomized trials have already shown cardiovascular and renal benefits of SGLT2 inhibitors in broader heart failure and CKD populations, but this observational cohort applies similar drugs specifically to HFpEF with detailed vascular and metabolomic profiling, making the mechanistic approach relatively novel.

Eligibility criteria

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 this trial is running

Iași

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

Conditions: CKD - Chronic Kidney Disease, Heart Failure Preserved Ejection Fraction, SGLT2 Inhibitors, Diabetes, CKD, HFpEF, SGTL2 inhibitors, Biomarkers