Heart FailureSGLT2-RISENCT07478575
Effects of SGLT2 Inhibitors on Erythropoiesis in Heart Failure
An observational study of Heart Failure and Anemia, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
This retrospective cohort study investigates the effects of SGLT2 inhibitor therapy on erythropoiesis and its association with cardiac and renal outcomes in patients with chronic heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Anemia, Renal Insufficiency
- How many people
- 85 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Jan 2019to 31 Dec 2026
- 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 chronic heart failure on guideline-directed medical therapy.
Who may be able to join
- Diagnosis of chronic heart failure
- Receiving guideline-directed medical therapy for heart failure for at least 3 months prior to inclusion
- Age ≥18 years
Who cannot join
- Incomplete or missing data in electronic medical records
- Acute cardiac event within 3 months prior to baseline
- Active malignancy or hematological disease affecting erythropoiesis
- Use of erythropoiesis-stimulating agents or regular erythrocyte transfusions during the observation period
- Severe renal insufficiency (eGFR <15 mL/min/1.73m²)
- Severe liver insufficiency (AST/ALT >3× upper limit of normal, bilirubin >2× upper limit of normal)
- Known allergy to any SGLT2 inhibitor component
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of SGLT2 Inhibitors on Erythropoiesis and Associated Cardio-Renal Outcomes in Heart Failure Patients: A Retrospective Cohort Study
This retrospective cohort study investigates the effects of SGLT2 inhibitor therapy on erythropoiesis and its association with cardiac and renal outcomes in patients with chronic heart failure. The study will compare hematological parameters, echocardiographic measures, and clinical outcomes between patients who initiated SGLT2 inhibitor therapy and a matched control group receiving guideline-directed medical therapy alone over a 12-month follow-up period.
Read the detailed description
The study is designed as a retrospective cohort analysis of patients with chronic heart failure who attended the outpatient heart failure clinics at University Medical Centre Ljubljana between January 1, 2019, and December 31, 2023. Patients will be divided into two groups: those who initiated SGLT2 inhibitor therapy (empagliflozin or dapagliflozin 10 mg daily) and a control group of comparable patients receiving guideline-directed medical therapy without SGLT2 inhibitors. Data will be extracted from electronic medical records at baseline, 6 months, and 12 months. The primary focus is on changes in erythropoietic parameters (hemoglobin, hematocrit, red blood cell count, red cell distribution width) and their association with changes in cardiac function (LVEF, NTproBNP, NYHA class) and renal function (eGFR, serum creatinine).
- Conditions
- Heart Failure, Anemia, Renal Insufficiency
- Keywords
- SGLT2 inhibitors, Heart Failure, Erythropoiesis, Anemia
- Medical subject headings
- Heart Failure, Anemia, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SGLT2 Inhibitor Group | Patients with chronic heart failure who initiated SGLT2 inhibitor therapy (empagliflozin 10 mg daily or dapagliflozin 10 mg daily) and continued treatment for at least 12 months, in addition to background guideline-directed medical therapy. | |
| Control Group | Patients with chronic heart failure receiving guideline-directed medical therapy without SGLT2 inhibitors, matched for key baseline characteristics. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hemoglobin levels
Change in hemoglobin (g/L)
Measured: Baseline to 12 months
Secondary outcomes (6)
Change in left ventricular ejection fraction
Change in left ventricular ejection fraction (LVEF, %)
Measured: Baseline to 12 months
Change in left ventricular end-diastolic volume
Change in left ventricular end-diastolic volume (LVEDV, mL)
Measured: Baseline to 12 months
Change in left ventricular end-systolic volume
Change in left ventricular end-systolic volume (LVESV, mL)
Measured: Baseline to 12 months
Change in N-terminal pro-B-type natriuretic peptide levels
Change in N-terminal pro-B-type natriuretic peptide (NTproBNP, pg/mL)
Measured: Baseline to 12 months
Change in renal function
Changes in serum creatinine (µmol/L)
Measured: Baseline to 12 months
Change in parameters of iron metabolism
Changes in serum iron (µmol/L).
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start1 Jan 2019
- Primary completion31 Dec 2024
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- Slovenian Research Agency
- Responsible party
- Principal investigator, Gregor Poglajen, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478575
- Sponsor's protocol ID
- 0120-664/2025-2711-3
- Acronym
- SGLT2-RISE
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data (IPD) that underline the results reported in future publications (text, tables, figures, and appendices) will be shared upon reasonable request. Shared IPD will include baseline characteristics, outcome measures, and relevant biomarker data, excluding data that could compromise participant privacy or institutional confidentiality.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of SGLT2 Inhibitors on Erythropoiesis and Associated Cardio-Renal Outcomes in Heart Failure Patients: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07478575
- Acronym / sponsor ID
- SGLT2-RISE / 0120-664/2025-2711-3
- Conditions
- Heart Failure, Anemia, Renal Insufficiency
- Keywords
- SGLT2 inhibitors, Heart Failure, Erythropoiesis, Anemia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Collaborators
- Slovenian Research Agency
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Mar 2026 (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.
This retrospective cohort study investigates the effects of SGLT2 inhibitor therapy on erythropoiesis and its association with cardiac and renal outcomes in patients with chronic heart failure. The study will compare hematological parameters, echocardiographic measures, and clinical outcomes between patients who initiated SGLT2 inhibitor therapy and a matched control group receiving guideline-directed medical therapy alone over a 12-month follow-up period.
Detailed description
The study is designed as a retrospective cohort analysis of patients with chronic heart failure who attended the outpatient heart failure clinics at University Medical Centre Ljubljana between January 1, 2019, and December 31, 2023. Patients will be divided into two groups: those who initiated SGLT2 inhibitor therapy (empagliflozin or dapagliflozin 10 mg daily) and a control group of comparable patients receiving guideline-directed medical therapy without SGLT2 inhibitors. Data will be extracted from electronic medical records at baseline, 6 months, and 12 months. The primary focus is on changes in erythropoietic parameters (hemoglobin, hematocrit, red blood cell count, red cell distribution width) and their association with changes in cardiac function (LVEF, NTproBNP, NYHA class) and renal function (eGFR, serum creatinine).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SGLT2 Inhibitor Group | – | –Patients with chronic heart failure who initiated SGLT2 inhibitor therapy (empagliflozin 10 mg daily or dapagliflozin 10 mg daily) and continued treatment for at least 12 months, in addition to background guideline-directed medical therapy. |
| Control Group | – | –Patients with chronic heart failure receiving guideline-directed medical therapy without SGLT2 inhibitors, matched for key baseline characteristics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic heart failure on guideline-directed medical therapy.
Key inclusion criteria (3 listed)
- Diagnosis of chronic heart failure
- Receiving guideline-directed medical therapy for heart failure for at least 3 months prior to inclusion
- Age ≥18 years
Key exclusion criteria (8 listed)
- Incomplete or missing data in electronic medical records
- Acute cardiac event within 3 months prior to baseline
- Active malignancy or hematological disease affecting erythropoiesis
- Use of erythropoiesis-stimulating agents or regular erythrocyte transfusions during the observation period
- Severe renal insufficiency (eGFR <15 mL/min/1.73m²)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in hemoglobin levels
Time frame: Baseline to 12 months
Change in hemoglobin (g/L)
6 secondary outcomes
Change in left ventricular ejection fraction
Time frame: Baseline to 12 months
Change in left ventricular end-diastolic volume
Time frame: Baseline to 12 months
Change in left ventricular end-systolic volume
Time frame: Baseline to 12 months
Change in N-terminal pro-B-type natriuretic peptide levels
Time frame: Baseline to 12 months
Change in renal function
Time frame: Baseline to 12 months
Change in parameters of iron metabolism
Time frame: Baseline to 12 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 17 Mar 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data (IPD) that underline the results reported in future publications (text, tables, figures, and appendices) will be shared upon reasonable request. Shared IPD will include baseline characteristics, outcome measures, and relevant biomarker data, excluding data that could compromise participant privacy or institutional confidentiality.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Heart Failure and Anemia, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 3 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 17 Mar 2026. 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 Slovenia. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hemoglobin levels (time frame: Baseline to 12 months). 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 17 Mar 2026.