Empagliflozin and Red Blood Cell 2,3-biphosphoglycerate Levels

Aristotle University Of Thessaloniki

Status: Enrolling

Conditions: Cardiovascular Prevention; SGLT2-Inhibitors; Tissue Oxygenation; Empagliflozin; Hematocrit Change

Treatments: Drug: Empagliflozin10Mg Tab

Study type: Observational

Funder types: Other

Identifiers

NCT06284850

Christina Trakatelli

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 1 patient group

treatment with empagliflozin 10mg od

Description:

empagliflozin 10mg OD

Treatment:

Drug: Empagliflozin10Mg Tab