Empagliflozin and Red Blood Cell 2,3-biphosphoglycerate Levels

Launched by ARISTOTLE UNIVERSITY OF THESSALONIKI · Feb 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called empagliflozin, which is typically used to help manage blood sugar levels in people with type 2 diabetes. Researchers want to see if empagliflozin can change the levels of a substance in red blood cells that helps deliver oxygen to tissues in the body. They believe that this change might play a role in protecting the heart and kidneys of patients who take SGLT-2 inhibitors like empagliflozin.

To participate in this study, you must be at least 18 years old and have certain health conditions, such as type 2 diabetes, heart failure, or chronic kidney disease. However, there are some conditions that would prevent you from joining, such as already being on an SGLT-2 inhibitor, having low or very high hemoglobin levels, or certain blood disorders. If you qualify and choose to participate, you will take empagliflozin once daily for the study period. This trial is currently recruiting participants, and it's an opportunity to contribute to important research that could improve treatments for heart and kidney health.

Gender

ALL

Eligibility criteria

• 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