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

NCT07237451 | Recruiting

• 1 other identifier: CARE FOR CKD HFPEF
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

CKD; HFpEF; SGTL2 inhibitors; Biomarkers; PWV

Outcome Measures

Primary Outcomes (2)

• MACE

  Composite CV outcome: time to first non-fatal myocardial infarction, non-fatal stroke, and hospitalization for heart failure or CV death

  20 months

• All-cause mortality

  All-cause mortality

  10 and 20 months

Secondary Outcomes (1)

• Composite renal outcome

  10 and 20 months

Other Outcomes (2)

• Changes in cardiac biomarkers

  Baseline, 10 and 20 months

• Changes in the NMR metabolomics and uremic toxins mapping

  Baseline, 10 and 20 months

Study Arms (2)

iSGLT2 therapy

CKD and HFpEF with iSGLT2 therapy

Diagnostic Test: Arterial stiffness; Diagnostic Test: Echocardiography; Other: Biomarkers determination; Other: NMR metabolomics and uremic toxins mapping

Control

CKD and HFpEF without iSGLT2 therapy

Diagnostic Test: Arterial stiffness; Diagnostic Test: Echocardiography; Other: Biomarkers determination; Other: NMR metabolomics and uremic toxins mapping

Interventions

Arterial stiffness DIAGNOSTIC_TEST

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.

Control; iSGLT2 therapy

Echocardiography DIAGNOSTIC_TEST

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).

Control; iSGLT2 therapy

Biomarkers determination OTHER

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

Control; iSGLT2 therapy

NMR metabolomics and uremic toxins mapping OTHER

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.

Control; iSGLT2 therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with CKD stages 3 and 4 (eGFR calculated by CKD-EPI) with HFpEF

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).

Sponsors & Collaborators

• Grigore T. Popa University of Medicine and Pharmacy: lead
• Dr. C.I. Parhon Hospital, Iasi: collaborator
• The Executive Agency for Higher Education, Research, Development and Innovation Funding: collaborator

Study Sites (1)

Dr. C.I. Parhon Hospital in Iasi

Iași, Romania

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Heart Failure, Diastolic; Diabetes Mellitus

Interventions

Vascular Stiffness; Echocardiography

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Failure; Heart Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 13, 2025
• First Posted: November 19, 2025
• Study Start: January 8, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 19, 2025

Record last verified: 2025-01

Locations

RO (1)