Cardiovascular Prevention, Empagliflozin, Hematocrit Change, SGLT2-Inhibitors, Tissue Oxygenation
Conditions
Brief 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.
Interventions
TB JARDIANCE 10MG
Sponsors
Aristotle University Of Thessaloniki
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in red blood cell 2,3-biphosphoglycerate levels (μmol/ml) | 12 weeks | Mean change in red blood cell 2,3-biphosphoglycerate levels (μmol/ml) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hb (mg/dl) | 12 weeks | Mean change in Hb (mg/dl) |
| RBC (x1000000/μl) | 12 weeks | Mean change in RBC (x1000000/μl) |
| MCV (fl), | 12 weeks | Mean change in MCV (fl) |
| Mean change in Hct (%) | 12 weeks | Mean change in Hct(%) |
| erythropoietin (mU/ml) | 12 weeks | Mean change in erythropoietin (mU/ml) |
| eGFR (ml/min/1.73m2), | 12 weeks | Mean change in eGFR (ml/min/1.73m2), |
| Urine Albumin to Creatinine Ratio (mg/g) | 12 weeks | Mean change in Urine Albumin to Creatinine Ratio (mg/g) |
| HbA1c (%, mmol/mol), | 12 weeks | Mean change inHbA1c (%, mmol/mol) |
Countries
Greece
Contacts
Primary ContactKONSTANTINOS KITSIOS, MD,MSc,PhD
Outcome results
None listed