The Effect of Ferric Carboximaltose on Intra-myocardial Iron Load Assessed by Cardiac Magnetic Resonance in Patients With Heart Failure With Reduced Ejection Fraction (HFREF).
试验速览
- 阶段
- 4 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Absolut changes in left ventricular ejection fraction
研究概览
简要总结
In general, anemia is associated with a greater presence of HF symptoms, worsening NYHA functional class, higher rate of hospitalization for heart failure, and reduced survival. However, it is unclear whether anemia is the cause of decreased survival or a marker for more advanced disease. Correction of iron deficiency in patients with New York Heart Association (NYHA) class II or III HF using intravenous iron (Ferinject®) improved "overall patient self-assessment" and NYHA functional class of 6-minute walk and health-related quality of life) in the FAIR-HF trial.
It is unknown if iron deficiency is correlated with intra-myocardial iron load as assessed by cardiac magnetic resonance (CMR) and if the treatment with intravenous iron has any impact on intra-myocardial iron load and left ventricular function.
The aim of the present study is to evaluate the effect of intravenous iron replacement on intra-myocardial iron deposits and the effect on left ventricular function.
Because it is a pilot study with few data in the literature, it is planned to use an initial sample of 20 patients.
We aim to evaluate the global ventricular function, the iron load by the T2 * method, the cardiac strain, the "Fiddle" and the "Fat water" of each patient by CMR. After this examination, patients will undergo intravenous infusion of 1g of Ferric Carboxymaltose (Ferinject®).
A comparative analysis of the ejection fraction values at the beginning and at the end of the study by CMR will be performed, in addition to a clinical reassessment.
The inclusion criteria will be: Patients older than 18 years, with iron deficiency and reduced ejection fraction defined as: serum ferritin <100 μg / L or with ferritin 100-299 μg / L with transferrin saturation <20 %; Hemoglobin <12g / dL in women and <13g / dL in men; Clinical stability in the last 3 months; Left ventricular ejection fraction (LVEF) <40% assessed by transthoracic echocardiography or CMR in the last 3 months. The exclusion criteria will be: patients with preserved ejection fraction (> 50%), pregnant women, refusal to participate in the present study, implantable pacemaker or implantable defibrillator incompatible with MRI, cerebral cerebral aneurysm clip and/or intracerebral or intraocular metal fragments, electronic cochlear implants, patients with claustrophobia, patients with clinical or hemodynamic instability and patients with indication for blood transfusion (Hb ≤ 7g / dL).
详细描述
Anemia (defined as a hemoglobin concentration below 13 g / dL in men and less than 12 g / dL in women) is a condition frequently associated with heart failure (HF), and its prevalence is estimated at around 4% to 50 %, depending on the study population and the adopted definition.
In general, anemia is associated with a greater presence of HF symptoms, worsening NYHA functional class, higher rate of hospitalization for heart failure, and reduced survival. However, it is unclear whether anemia is the cause of decreased survival or a marker for more advanced disease.
The etiology of anemia is multifactorial, including reduced sensitivity to erythropoietin receptors, presence of a hematopoiesis inhibitor and / or a defective iron supply for erythropoiesis. There is growing evidence that iron availability may be reduced absolutely due to decreased enteral iron absorption and / or occult hemorrhage, as well as in relative form, resulting from the dysregulation of iron homeostasis and accumulation of iron in cells of the reticuloendothelial system, characteristic of chronic disease anemia.
Recently, it has been suggested that iron deficiency itself may be an independent predictor of outcome in HF.
Correction of iron deficiency in patients with New York Heart Association (NYHA) class II or III HF using intravenous iron (Ferinject®) improved "overall patient self-assessment" and NYHA functional class of 6-minute walk and health-related quality of life) in the FAIR-HF trial. The treatment of patients with heart failure with mild to moderate anemia (hemoglobin levels from 9.0 to 12.0 g / dL) with the erythropoietin analogue, darbepoetin alfa was evaluated in the RED-HF trial (Reduction of Events with Darbepoetin Alfa in Heart Failure). No differences in the primary end point of death from any cause or hospitalization due to HF, or in the secondary outcome of cardiovascular death or time until the first hospitalization due to HF. The absence of darbepoetin was consistent across all subgroups. Of relevant, treatment with darbepoetin alfa led to an early increase (within one month) and sustained in the hemoglobin level throughout the study. These RED-HF trial results suggest that the level of hemoglobin, as well as other sub- stantial outcomes in HF, may be a prognostic marker, with decreased levels correlated with a worse prognosis, rather than a therapeutic target of HF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Left ventricular ejection fraction <40% assessed by transthoracic echocardiography or cardiac magnetic resonance with at least 3 months.
- •Serum ferritin < 100µg/L or 100-299µg/L with transferrin saturation < 20%
- •clinical stability during last 3 months
排除标准
- •Use of intracardiac defibrillator or pacemaker.
- •Severe to moderate valvar heart disease
- •Clinical instability, acute coronary syndrome and cardiac surgery within 3 months.
研究组 & 干预措施
Iron Reposition
The selected patients will receive 1g of ferric carboxymaltose applied intravenously after dilution in 100ml of crystalline solution. the infusion time will be around 15 minutes realized at the moinhos the vento infusion center.
干预措施: Ferric carboxymaltose (Drug)
结局指标
主要结局
Absolut changes in left ventricular ejection fraction
时间窗: 30 days
Compare the left ventricular ejection fraction 30 days after receiving 1g of ferric carboxymaltose intravenously.
次要结局
未报告次要终点