Effects of SGLT2 Inhibitors on Erythropoiesis and Associated Cardio-Renal Outcomes in Heart Failure Patients: A Retrospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Change in hemoglobin levels
研究概览
简要总结
This retrospective cohort study investigates the effects of SGLT2 inhibitor therapy on erythropoiesis and its association with cardiac and renal outcomes in patients with chronic heart failure. The study will compare hematological parameters, echocardiographic measures, and clinical outcomes between patients who initiated SGLT2 inhibitor therapy and a matched control group receiving guideline-directed medical therapy alone over a 12-month follow-up period.
详细描述
The study is designed as a retrospective cohort analysis of patients with chronic heart failure who attended the outpatient heart failure clinics at University Medical Centre Ljubljana between January 1, 2019, and December 31, 2023. Patients will be divided into two groups: those who initiated SGLT2 inhibitor therapy (empagliflozin or dapagliflozin 10 mg daily) and a control group of comparable patients receiving guideline-directed medical therapy without SGLT2 inhibitors. Data will be extracted from electronic medical records at baseline, 6 months, and 12 months. The primary focus is on changes in erythropoietic parameters (hemoglobin, hematocrit, red blood cell count, red cell distribution width) and their association with changes in cardiac function (LVEF, NTproBNP, NYHA class) and renal function (eGFR, serum creatinine).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Diagnosis of chronic heart failure
- •Receiving guideline-directed medical therapy for heart failure for at least 3 months prior to inclusion
- •Age ≥18 years
排除标准
- •Incomplete or missing data in electronic medical records
- •Acute cardiac event within 3 months prior to baseline
- •Active malignancy or hematological disease affecting erythropoiesis
- •Use of erythropoiesis-stimulating agents or regular erythrocyte transfusions during the observation period
- •Severe renal insufficiency (eGFR <15 mL/min/1.73m²)
- •Severe liver insufficiency (AST/ALT >3× upper limit of normal, bilirubin >2× upper limit of normal)
- •Known allergy to any SGLT2 inhibitor component
- •Pregnancy or breastfeeding
研究组 & 干预措施
Control Group
Patients with chronic heart failure receiving guideline-directed medical therapy without SGLT2 inhibitors, matched for key baseline characteristics.
SGLT2 Inhibitor Group
Patients with chronic heart failure who initiated SGLT2 inhibitor therapy (empagliflozin 10 mg daily or dapagliflozin 10 mg daily) and continued treatment for at least 12 months, in addition to background guideline-directed medical therapy.
结局指标
主要结局
Change in hemoglobin levels
时间窗: Baseline to 12 months
Change in hemoglobin (g/L)
次要结局
- Change in left ventricular ejection fraction(Baseline to 12 months)
- Change in left ventricular end-diastolic volume(Baseline to 12 months)
- Change in left ventricular end-systolic volume(Baseline to 12 months)
- Change in N-terminal pro-B-type natriuretic peptide levels(Baseline to 12 months)
- Change in renal function(Baseline to 12 months)
- Change in parameters of iron metabolism(Baseline to 12 months)
研究者
Gregor Poglajen
MD, PhD
University Medical Centre Ljubljana