Effect of Combination of Intravenous Iron and SGLT2 Inhibitor on Ventricular Function and Myocardial Iron Content in Patients With Heart Failure and Iron Deficiency.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- left ventricular function assessed (LVEF) by CMR.
研究概览
简要总结
Background. Treatment with intravenous iron has been shown to improve symptoms, functional capacity, and quality of life in patients with heart failure with reduced ejection fraction (HFrEF) and iron deficiency. However, the mechanisms underlying these beneficial effects remain unknown. SGLT2i seem to alter hematocrit and other hematological markers or iron content.
This study aims to measure cardiac magnetic resonance changes in myocardial iron content and in left ventricular function after administration of intravenous iron with and without the concomitant use of SGLT2 inhibitor in patients with HFrEF and iron deficiency.
详细描述
Background. Treatment with intravenous iron has been shown to improve symptoms, functional capacity, and quality of life in patients with heart failure with reduced ejection fraction (HFrEF) and iron deficiency. However, the mechanisms underlying these beneficial effects remain unknown. SGLT2i seem to alter hematocrit and other hematological markers or iron content. This study aims to measure cardiac magnetic resonance changes in myocardial iron content after administration of intravenous iron and to assess changes in left ventricular function in patients with HFrEF and iron deficiency.
Methods. Ninety-nine outpatient with symptomatic HFrEF, left ventricular ejection fraction (LVEF) <40%, SGLT2i naive, and iron deficiency will be assigned, to receive intravenous iron + SGLT2i; or intravenous iron + placebo of SGLT2i; or placebo of both therapies for 30 days. Myocardial iron will be evaluated by T2-star (T2*) cardiac magnetic resonance (CMR) sequencing before intravenous iron infusion. After 30 days, all patients will be reassessed by T2* CMR sequencing. The primary endpoint will be changes in LVEF and myocardial iron content at 30 days. Secondary endpoints will include correlations of these changes with myocardial iron content, functional capacity, quality of life, and cardiac biomarkers.
Conclusions. This study will determine the effect of ferric carboxymaltose and its combination with SGLT2i on LVEF and its relationship with measures of myocardial iron content, functional capacity, and biomarkers in HFrEF and iron deficiency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
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
- •Age 18 years or over;
- •Ejection fraction (EF) ≤40%, estimated by color Doppler echocardiography or CMR or radionuclide ventriculography;
- •Serum ferritin <100 µg/L or serum ferritin between 100 and 299 µg/L and transferrin saturation <20%;
- •Serum hemoglobin between 9.5 and 13.5 mg/dL;
- •Patients must be SGLT2 naive;
- •Informed consent form (ICF) signed.
排除标准
- •Kidney disease requiring dialysis or chronic kidney disease not requiring dialysis with an estimated glomerular filtration rate <30 mL/min/1.73 m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation;
- •Severe primary valve disease;
- •Acute coronary syndrome requiring cardiac surgery or coronary artery bypass surgery in the past 3 months;
- •Patients already being treated for some type of non-iron deficiency anemia;
- •Blood transfusion within 30 days prior to CMR examination;
- •Patients with a pacemaker, cardiac resynchronization therapy, or implantable defibrillator;
- •Diagnosis of hemochromatosis.
研究组 & 干预措施
ferric carboxymaltose + SGLT2 inhibitor
Patients will receive 2 vials of ferric carboxymaltose 500 mg (Ferinject® 500 mg, Vifor-Pharma) IV, once; and Dapagliflozin 10 mg PO, once a day, for 30 days.
干预措施: Iron Carboxymaltose (Drug)
ferric carboxymaltose + SGLT2 inhibitor
Patients will receive 2 vials of ferric carboxymaltose 500 mg (Ferinject® 500 mg, Vifor-Pharma) IV, once; and Dapagliflozin 10 mg PO, once a day, for 30 days.
干预措施: Dapagliflozin 10mg Tab (Drug)
ferric carboxymaltose + placebo of SGLT2 inhibitor
Patients will receive 2 vials of ferric carboxymaltose 500 mg (Ferinject® 500 mg, Vifor-Pharma) IV, once; and placebo PO, once a day, for 30 days.
干预措施: Iron Carboxymaltose (Drug)
ferric carboxymaltose + placebo of SGLT2 inhibitor
Patients will receive 2 vials of ferric carboxymaltose 500 mg (Ferinject® 500 mg, Vifor-Pharma) IV, once; and placebo PO, once a day, for 30 days.
干预措施: Placebo of Dapagliflozin (Drug)
Placebo of ferric carboxymaltose and placebo of SGLT2 inhibitor
Patients will receive 2 vials of placebo IV, once; and placebo PO, once a day, for 30 days.
干预措施: Placebo of Iron Carboxymaltose (Drug)
Placebo of ferric carboxymaltose and placebo of SGLT2 inhibitor
Patients will receive 2 vials of placebo IV, once; and placebo PO, once a day, for 30 days.
干预措施: Placebo of Dapagliflozin (Drug)
结局指标
主要结局
left ventricular function assessed (LVEF) by CMR.
时间窗: 30 days
LVEF assessed by Cardiac Magnetic Resonance
次要结局
- myocardial strain assessed by T2* CMR(30 days)
- Myocardial iron content assessed by T2* CMR(30 days)
研究者
Luis Beck Da Silva Neto
Professor of Medicine
Hospital de Clinicas de Porto Alegre