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NCT Number: NCT07478575

Effects of SGLT2 Inhibitors on Erythropoiesis in Heart Failure

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change in hemoglobin levels

    Time frame: Baseline to 12 months

    Change in hemoglobin (g/L)

Secondary outcomes

  1. Change in left ventricular ejection fraction

    Time frame: Baseline to 12 months

    Change in left ventricular ejection fraction (LVEF, %)

  2. Change in left ventricular end-diastolic volume

    Time frame: Baseline to 12 months

    Change in left ventricular end-diastolic volume (LVEDV, mL)

  3. Change in left ventricular end-systolic volume

    Time frame: Baseline to 12 months

    Change in left ventricular end-systolic volume (LVESV, mL)

  4. Change in N-terminal pro-B-type natriuretic peptide levels

    Time frame: Baseline to 12 months

    Change in N-terminal pro-B-type natriuretic peptide (NTproBNP, pg/mL)

  5. Change in renal function

    Time frame: Baseline to 12 months

    Changes in serum creatinine (µmol/L)

  6. Change in parameters of iron metabolism

    Time frame: Baseline to 12 months

    Changes in serum iron (µmol/L).

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Collaborators

  • Slovenian Research Agency

Registry information

Official study title

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

Acronym: SGLT2-RISE

Important dates

Study start
2019
Primary completion
2024
Study completion
2026
First posted
Mar 17, 2026
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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