NCT06284850招募中不适用
Red Blood Cell 2,3-biphosphoglycerate Levels in Patients Treated With Empagliflozin. A Prospective Cohort Study.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Mean change in red blood cell 2,3-biphosphoglycerate levels (μmol/ml)
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
treatment with empagliflozin 10mg od
empagliflozin 10mg OD
干预措施: Empagliflozin10Mg Tab (Drug)
结局指标
主要结局
Mean change in red blood cell 2,3-biphosphoglycerate levels (μmol/ml)
时间窗: 12 weeks
Mean change in red blood cell 2,3-biphosphoglycerate levels (μmol/ml)
次要结局
- HbA1c (%, mmol/mol),(12 weeks)
- RBC (x1000000/μl)(12 weeks)
- Hb (mg/dl)(12 weeks)
- eGFR (ml/min/1.73m2),(12 weeks)
- erythropoietin (mU/ml)(12 weeks)
- Mean change in Hct (%)(12 weeks)
- MCV (fl),(12 weeks)
- Urine Albumin to Creatinine Ratio (mg/g)(12 weeks)
研究者
Christina Trakatelli
Assistant Professor Of Internal Medicine
Aristotle University Of Thessaloniki
研究点 (1)
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