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Empagliflozin and Red Blood Cell 2,3-biphosphoglycerate Levels

Empagliflozin and Red Blood Cell 2,3-biphosphoglycerate Levels

Recruiting
18 years and older
All
Phase N/A

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Overview

The aim of this study is to investigate the hypothesis that treatment with empagliflozin may have an impact on red blood cell 2,3-biphosphoglycerate levels affecting tissue oxygen supply and thus mediating part of the cardio- and reno- protective effect of SGLT-2 inhibitors.

Eligibility

Inclusion Criteria:

Patients>18 year-old and at least one of the following

  • Type 2 Diabetes Mellitus and HbA1c: 6.5-9.0% or HbA1c <6.5% and history of Coronary Artery Disease or Stroke not treated with GLP-1RA
  • Heart Failure defined as Ejection Fraction<40% or NT-proBNP>300pg/ml or Atrial fibrillation and NT-proBNP>900pg/ml
  • Chronic Kidney Disease defined as eGFR<60ml/min/1.73m2 (CKPD- EPI) or/and UACR>200mg/g Initiating treatment with empagliflozin 10mg once daily as add on treatment

Exclusion Criteria:

  • Patients already treated with an SGLT-2 inhibitor
  • Patients with Hb<11gr/dl or>16gr/dl
  • Patients with history of inherited or acquired hemoglobin disease
  • Patients with history of hemolytic anemia
  • Patients with history of hematologic malignancy or myelodysplastic syndrome or myeloproliferative syndrome
  • Patients treated within the last 6 months for anemia due to iron, B12 or folate deficiency
  • Patients with history of major hemorrhage or major operation leading to RBC transfusion within the last 3 months.
  • Patients planning major operation or revascularization procedure within the 12 following weeks
  • Patients treated with erythropoietin
  • Patients with Chronic Kidney Disease and GFR<30ml/min/1.73m2
  • Pregnancy
  • Women of childbearing age not receiving appropriate contraception measures

Study details
    Hematocrit Change
    Cardiovascular Prevention
    Empagliflozin
    SGLT2-Inhibitors
    Tissue Oxygenation

NCT06284850

Aristotle University Of Thessaloniki

15 October 2025

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