An Open, Prospective, Randomized Study on the Efficacy of Iron Therapy Using Intravenous (IV) Iron Supplements Relative to Oral Iron Intake for Increasing Left Ventricular Systolic Function in Patients With Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 298
- 试验地点
- 1
- 主要终点
- Decrease in the Wall Motion Score Index
研究概览
简要总结
The OPERA-MI trial evaluates the effect of i.v. ferric carboxymaltose compared to the effect of oral iron, on left ventricular systolic function.
详细描述
For this study an open-label prospective randomized approach is used. During the study 360 patients with or without ID, who hospitalized for myocardial infarction were signed up. Patients were randomised (1:1) to either intravenous. FCM or oral ferrous sulphate and received the treatment during hospitalisation. Patients are closely followed for 1 year. The primary outcome is a decrease in the Wall Motion Score Index value in FCM group compered to ferrous sulphate group. The main secondary outcome includes the composite of cardio-vascular mortality, non-fatal stroke, non-fatal MI, recurrent heart failure hospitalizations.
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
- 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
- •Adult (≥18 years of age) able to provide informed consent. Hospitalized myocardial infarction patients (that diagnosed according to Fourth Universal Definition of myocardial infarction and myocardial injury, ESC 2018) with hypokinesia or akinesia in at least two connected left ventricular segments according to echocardiography results obtained within the first 24 hours after myocardial infarction occurs.
- •Hemoglobin >9.0 g/dL and <15,0 g/dl and serum iron <12 µmol/l on screening visit.
- •Serum ferritin <100 μg/L, or 100-299 μg/L when transferrin saturation <20%.
排除标准
- •Known hypersensitivity reaction to any component of ferric carboxymaltose.
- •History of acquired iron overload, or the recent receipt (within 3 months) of erythropoietin stimulating agent, i.v. iron therapy, or blood transfusion.
- •Heart failure Killip class II-IV on screening visit.
- •Current or planned mechanical circulatory support or heart transplantation.
- •Hemodialysis or peritoneal dialysis (current or planned within the next 6 months).
- •Documented liver disease, or active hepatitis (i.e. alanine transaminase or aspartate transaminase >3 times the upper limit of normal range).
- •Current or recent (within 3 years) malignancy with exception of basal cell carcinoma or squamous cell carcinoma of the skin, or cervical intraepithelial neoplasia.
- •Active gastrointestinal bleeding.
- •Female participant of child-bearing potential who is pregnant, lactating, or not willing to use adequate contraceptive precautions during the study and for up to 5 days after the last scheduled dose of study medication.
- •Inability to return for follow up visits within the necessary period of time.
研究组 & 干预措施
FCM group
The ferric carboxymaltose doses were determined using the patient's screening visit body weight measurement and haemoglobin value. Patients receives all doses during hospitalization accordance with the drug local labels.
干预措施: ferric carboxymaltose (Drug)
Ferrous sulphate group
100 mg of ferrous sulphate is administrated 2 times per day during hospitalization and continue within next 2 month.
干预措施: ferrous sulphate (Drug)
Group with normal iron status
Patiants with normal iron status
结局指标
主要结局
Decrease in the Wall Motion Score Index
时间窗: 1 year
Using a standard transthoracic echocardiography sequence, each myocardial segment is assigned a score from 1 to 3. we used the 16 segment model of myocardial segmentation Each segment is then scored, using the following criteria: normokinesia (1 point) normal wall thickening and endocardial excursion hypokinesia (2 points) reduced wall thickening, reduced endocardial excursion akinesia (3 points) The wall motion score index is then calculated by dividing the sum of the aforementioned segmental values by the number of myocardial segments (16). A WMSI of 1.0 (16/16) is considered normokinetic, and correlates with a CMRI calculated ejection fraction of 64%, whereas a WMSI of 3.0 correlates with an ejection fraction of 12% and is considered akinetic. There are no spetial units of measure for it.
次要结局
- Composite Outcome(1 year)
研究者
Dilyara Khastieva
Assistant Professor, PhD student
Kazan State Medical University