Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-24 @ 4:44 PM
NCT ID:
NCT06284850
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06284850
Study Brief:
Protocol Section:
NCT06284850