Empagliflozin and Red Blood Cell 2,3-biphosphoglycerate Levels

Cardiovascular Prevention Clinical Trial

Official title:

Red Blood Cell 2,3-biphosphoglycerate Levels in Patients Treated With Empagliflozin. A Prospective Cohort Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06284850
• Other study ID #: Christina Trakatelli
• Status: Recruiting
• Start date: November 30, 2023
• Est. completion date: November 2025

Study information

• Verified date: February 2024
• Source: Aristotle University Of Thessaloniki
• Contact: KONSTANTINOS KITSIOS, MD,MSc,PhD
• Phone: +306977295744
• Email: kitsios_k[@]yahoo.gr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Cardiovascular Prevention
• Hematocrit Change
• Tissue Oxygenation

Intervention

Drug:
• Empagliflozin10Mg Tab
TB JARDIANCE 10MG

Locations

Country	Name	City	State
Greece	Papageorgiou General Hospital	Thessaloniki	Central Macedonia

Sponsors (1)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in red blood cell 2,3-biphosphoglycerate levels (µmol/ml)	Mean change in red blood cell 2,3-biphosphoglycerate levels (µmol/ml)	12 weeks
Secondary	Mean change in Hct (%)	Mean change in Hct(%)	12 weeks
Secondary	Hb (mg/dl)	Mean change in Hb (mg/dl)	12 weeks
Secondary	RBC (x1000000/µl)	Mean change in RBC (x1000000/µl)	12 weeks
Secondary	MCV (fl),	Mean change in MCV (fl)	12 weeks
Secondary	HbA1c (%, mmol/mol),	Mean change inHbA1c (%, mmol/mol)	12 weeks
Secondary	erythropoietin (mU/ml)	Mean change in erythropoietin (mU/ml)	12 weeks
Secondary	eGFR (ml/min/1.73m2),	Mean change in eGFR (ml/min/1.73m2),	12 weeks
Secondary	Urine Albumin to Creatinine Ratio (mg/g)	Mean change in Urine Albumin to Creatinine Ratio (mg/g)	12 weeks