CKD - Chronic Kidney DiseaseCARE FOR CKD HNCT07237451
Cardiovascular and Renal Endpoints With Flozins - an Observational Prospective Study in CKD HFpEF Patients
An observational study of CKD - Chronic Kidney Disease and Heart Failure Preserved Ejection Fraction, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CKD - Chronic Kidney Disease, Heart Failure Preserved Ejection Fraction, SGLT2 Inhibitors
- What is being tested?
- Arterial stiffness, Echocardiography and Biomarkers determination
- How many people
- 200 participants
- Where
- 1 siteRomania
- Study dates
- 8 Jan 2025to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with CKD stages 3 and 4 (eGFR calculated by CKD-EPI) with HFpEF
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Romania1 site, 1 recruiting
- Recruiting
Dr. C.I. Parhon Hospital in Iasi
Iași
Adrian Covic C Head of Nephrology Clinic, MD, PhD, +40232211818, adrian.covic@umfiasi.ro
Gianina Dodi Researcher, PhD, +40232211818, gianina.dodi@umfiasi.ro
About this study
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.
Read the detailed description
Chronic kidney disease (CKD) is considered to become the 5th cause of death worldwide by 2040. Aging populations, growing frequency of type 2 diabetes, hypertension, a low detection rate and therapeutic inertia in the early stages of CKD determined the increasing incidence and prevalence. CKD patients exhibit an elevated cardiovascular risk manifesting myocardial infarction and stroke, coronary artery disease, heart failure (HF), arrhythmias, and sudden cardiac death. The relationship between HF and CKD is bidirectional, with chronic HF promoting CKD development (cardio-renal syndrome type 1), and CKD promoting the development of HF (type 3). In the last decade, HF with preserved ejection fraction (HFpEF) represents the typical phenotype in patients with CKD, accounting for more than half of the cases of HF. Given the high burden of both HF and CKD, their complex interaction and challenging management, along with the prognostic implications regarding comorbidity and mortality, a comprehensive approach in the HFpEF population is mandatory, since HF diagnosis was evasive for years. 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.
The objectives of this prospective observational study are to determine:
- the feasibility of PWV measurement and ventricular strain in HFpEF CKD patients with and without SGLT2 inhibition;
- the cardiovascular outcomes, namely MACE, defined as time to first non-fatal myocardial infarction, non-fatal stroke, hospitalization for heart failure or CV death and on all-cause mortality in HFpEF CKD patients with and without SGLT2 inhibition;
- the renal outcomes, such as rapid progression of renal disease - defined as sustained annual decline of at least 5mL/min/1,73m2 in eGFR or a sustained drop of 25% or more in eGFR within 12 months;
- the metabolomics profile related to uremic toxins panel determined by NMR spectroscopy and other biological markers as novel molecules with a higher potential accuracy of predicting further major cardiovascular events in HFpEF CKD patients with and without SGLT2 inhibition.
- Conditions
- CKD - Chronic Kidney Disease, Heart Failure Preserved Ejection Fraction, SGLT2 Inhibitors, Diabetes (DM)
- Being tested
- Arterial stiffness, Echocardiography, Biomarkers determination, NMR metabolomics and uremic toxins mapping
- Keywords
- CKD, HFpEF, SGTL2 inhibitors, Biomarkers, PWV
- Medical subject headings
- Renal Insufficiency, Chronic, Heart Failure, Diastolic, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial stiffnessDiagnostic 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.
EchocardiographyDiagnostic 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).
Biomarkers determinationOther
NT-pro BNP, Syndecan-1, VCAM-1, Endoglin, NO and ADMA will be determined by specific enzyme linked immunosorbent assay (ELISA) kits.
NMR metabolomics and uremic toxins mappingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| iSGLT2 therapy | CKD and HFpEF with iSGLT2 therapy Receives: Diagnostic Test: Arterial stiffness; Diagnostic Test: Echocardiography; Other: Biomarkers determination; Other: NMR metabolomics and uremic toxins mapping | |
| Control | CKD and HFpEF without iSGLT2 therapy Receives: Diagnostic Test: Arterial stiffness; Diagnostic Test: Echocardiography; Other: Biomarkers determination; Other: NMR metabolomics and uremic toxins mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
Composite CV outcome: time to first non-fatal myocardial infarction, non-fatal stroke, and hospitalization for heart failure or CV death
Measured: 20 months
All-cause mortality
All-cause mortality
Measured: 10 and 20 months
Secondary outcomes (1)
Composite renal outcome
Rapid progression of renal disease - defined as sustained annual decline of at least 5mL/min/1,73m2 in eGFR or a sustained drop of 25% or more in eGFR within 10 months
Measured: 10 and 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start8 Jan 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CKD - Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grigore T. Popa University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. C.I. Parhon Hospital, Iasi, The Executive Agency for Higher Education, Research, Development and Innovation Funding
- Responsible party
- Principal investigator, Adrian Covic, Grigore T. Popa University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07237451
- Sponsor's protocol ID
- CARE FOR CKD HFPEF
- Acronym
- CARE FOR CKD H
- Status last verified
- Jan 2025
- First submitted
- 13 Nov 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular and Renal Endpoints With Flozins - an Observational Prospective Study in CKD HFpEF Patients
- ClinicalTrials.gov ID
- NCT07237451
- Acronym / sponsor ID
- CARE FOR CKD H / CARE FOR CKD HFPEF
- Conditions
- CKD - Chronic Kidney Disease, Heart Failure Preserved Ejection Fraction, SGLT2 Inhibitors, Diabetes (DM)
- Keywords
- CKD, HFpEF, SGTL2 inhibitors, Biomarkers, PWV
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Grigore T. Popa University of Medicine and PharmacyUniversity, hospital or other
- Collaborators
- Dr. C.I. Parhon Hospital, Iasi, The Executive Agency for Higher Education, Research, Development and Innovation Funding
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic kidney disease (CKD) is considered to become the 5th cause of death worldwide by 2040. Aging populations, growing frequency of type 2 diabetes, hypertension, a low detection rate and therapeutic inertia in the early stages of CKD determined the increasing incidence and prevalence. CKD patients exhibit an elevated cardiovascular risk manifesting myocardial infarction and stroke, coronary artery disease, heart failure (HF), arrhythmias, and sudden cardiac death. The relationship between HF and CKD is bidirectional, with chronic HF promoting CKD development (cardio-renal syndrome type 1), and CKD promoting the development of HF (type 3). In the last decade, HF with preserved ejection fraction (HFpEF) represents the typical phenotype in patients with CKD, accounting for more than half of the cases of HF. Given the high burden of both HF and CKD, their complex interaction and challenging management, along with the prognostic implications regarding comorbidity and mortality, a comprehensive approach in the HFpEF population is mandatory, since HF diagnosis was evasive for years. 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.
The objectives of this prospective observational study are to determine:
- the feasibility of PWV measurement and ventricular strain in HFpEF CKD patients with and without SGLT2 inhibition;
- the cardiovascular outcomes, namely MACE, defined as time to first non-fatal myocardial infarction, non-fatal stroke, hospitalization for heart failure or CV death and on all-cause mortality in HFpEF CKD patients with and without SGLT2 inhibition;
- the renal outcomes, such as rapid progression of renal disease - defined as sustained annual decline of at least 5mL/min/1,73m2 in eGFR or a sustained drop of 25% or more in eGFR within 12 months;
- the metabolomics profile related to uremic toxins panel determined by NMR spectroscopy and other biological markers as novel molecules with a higher potential accuracy of predicting further major cardiovascular events in HFpEF CKD patients with and without SGLT2 inhibition.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iSGLT2 therapy | – | Diagnostic Test: Arterial stiffness, Diagnostic Test: Echocardiography, Other: Biomarkers determination, Other: NMR metabolomics and uremic toxins mappingCKD and HFpEF with iSGLT2 therapy |
| Control | – | Diagnostic Test: Arterial stiffness, Diagnostic Test: Echocardiography, Other: Biomarkers determination, Other: NMR metabolomics and uremic toxins mappingCKD and HFpEF without iSGLT2 therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with CKD stages 3 and 4 (eGFR calculated by CKD-EPI) with HFpEF
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arterial stiffnessArterial 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 | Control, iSGLT2 therapy |
| EchocardiographyEchocardiography 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). | Diagnostic test | Control, iSGLT2 therapy |
| Biomarkers determinationNT-pro BNP, Syndecan-1, VCAM-1, Endoglin, NO and ADMA will be determined by specific enzyme linked immunosorbent assay (ELISA) kits. | Other | Control, iSGLT2 therapy |
| NMR metabolomics and uremic toxins mappingThe aliquoted serum preserved at -80° C will be analysed by NMR using deuterated solvents (D2O, CDCl3, CD3OD, CD3CN), standards of metabolites and uremic toxins. | Other | Control, iSGLT2 therapy |
Primary outcome
MACE
Time frame: 20 months
Composite CV outcome: time to first non-fatal myocardial infarction, non-fatal stroke, and hospitalization for heart failure or CV death
All-cause mortality
Time frame: 10 and 20 months
All-cause mortality
1 secondary outcome
Composite renal outcome
Time frame: 10 and 20 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CKD - Chronic Kidney Disease and Heart Failure Preserved Ejection Fraction, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (time frame: 20 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.