University Medical Centre Ljubljana
Ljubljana, 1000, Slovenia
NCT Number: NCT07478575
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Observational
Ljubljana, 1000, Slovenia
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline to 12 months
Change in hemoglobin (g/L)
Time frame: Baseline to 12 months
Change in left ventricular ejection fraction (LVEF, %)
Time frame: Baseline to 12 months
Change in left ventricular end-diastolic volume (LVEDV, mL)
Time frame: Baseline to 12 months
Change in left ventricular end-systolic volume (LVESV, mL)
Time frame: Baseline to 12 months
Change in N-terminal pro-B-type natriuretic peptide (NTproBNP, pg/mL)
Time frame: Baseline to 12 months
Changes in serum creatinine (µmol/L)
Time frame: Baseline to 12 months
Changes in serum iron (µmol/L).
University Medical Centre Ljubljana
Other
Effects of SGLT2 Inhibitors on Erythropoiesis and Associated Cardio-Renal Outcomes in Heart Failure Patients: A Retrospective Cohort Study
Acronym: SGLT2-RISE
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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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