Effects of SGLT2 Inhibitors on Erythropoiesis in Heart Failure

Effects of SGLT2 Inhibitors on Erythropoiesis and Associated Cardio-Renal Outcomes in Heart Failure Patients: A Retrospective Cohort Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07478575

Acronym

SGLT2-RISE

Enrollment

Registered

2026-03-17

Start date

2019-01-01

Completion date

2026-12-31

Last updated

2026-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Heart Failure, Renal Insufficiency

Keywords

SGLT2 inhibitors, Heart Failure, Erythropoiesis, Anemia

Brief 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. 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).

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosis of chronic heart failure * Receiving guideline-directed medical therapy for heart failure for at least 3 months prior to inclusion * Age ≥18 years

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Change in hemoglobin levels	Baseline to 12 months	Change in hemoglobin (g/L)

Secondary

Measure	Time frame	Description
Change in parameters of iron metabolism	Baseline to 12 months	Changes in serum iron (µmol/L).
Change in renal function	Baseline to 12 months	Changes in serum creatinine (µmol/L)
Change in left ventricular end-diastolic volume	Baseline to 12 months	Change in left ventricular end-diastolic volume (LVEDV, mL)
Change in left ventricular end-systolic volume	Baseline to 12 months	Change in left ventricular end-systolic volume (LVESV, mL)
Change in N-terminal pro-B-type natriuretic peptide levels	Baseline to 12 months	Change in N-terminal pro-B-type natriuretic peptide (NTproBNP, pg/mL)
Change in left ventricular ejection fraction	Baseline to 12 months	Change in left ventricular ejection fraction (LVEF, %)

Countries

Slovenia

Outcome results