Effect of intravenous ferric carboxymaltose on mortality and cardiovascular morbidity, and quality of life in iron deficient patients with recent myocardial infarction
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 29
- 主要终点
- 1) Time to all-cause death assessed up to maximum 36-months follow-up;
研究概览
简要总结
Evaluation of the effect of i.v. FCM treatment compared with placebo on the risk of death, the risk of heart failure events (HFE*) (number of events and time to first event), NTproBNP concentration and the change in quality of life (QoL) assessed using EQ-5D during the follow-up up to 36-months in patients with recent AMI and ID (with an implementation of a win ratio approach in a hierarchical descending order). *HFE: unplanned hospitalization for HF (including unplanned visit at emergency department due to HF), ambulatory significant intensification of diuretic therapy (either starting i.v. loop diuretic or more than doubling oral loop diuretic dose or de novo initiation of oral loop diuretic therapy due to HF signs/symptoms).
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Diagnosis of AMI (STEMI or NSTEMI) up to 4 weeks (28 days) before randomisation.
- •Presence of iron deficiency (ID) defined as transferrin saturation TSAT<20% assessed within up to 4 weeks (28 days) before randomisation.
- •Presence of ≥3 factors (confirmed within up to 4 weeks before randomisation) (note: at least one of a-c must be present): a. LVEF ≤50%; b. NT-proBNP ≥400 pg/mL for subjects in sinus rhythm and NT-proBNP ≥800 pg/mL for subjects with atrial fibrillation; c. Clinical features of congestion/volume overload (including Killip class II or more) requiring i.v. loop diuretic use; d. Diagnosis of diabetes mellitus (also de novo diagnosis); e. Diagnosis of atrial fibrillation (any time in the past or de-novo diagnosis); f. Multivessel coronary disease (regardless of completeness of revascularisation during an index AMI); g. Not complete revascularisation or/and no reperfusion (during an index AMI); h. History of AMI (despite an index AMI); i. eGFR <60 mL/min/1.73m2; j. Age ≥70 years.
- •Written informed consent.
排除标准
- •Subject temperature >38 ͦ C or any infection requiring antibiotic therapy within 48 hours prior to randomisation.
- •Subject has known active malignancy of any organ system, i.e., clinical evidence of current malignancy or not in stable remission for at least 3 years since completion of last treatment with exception of non-invasive basal cell carcinoma, squamous cell carcinoma of the skin or cervical intra-epithelial neoplasia.
- •Documented liver diseases.
- •Participation in a device or drug trial within 3 months prior to randomisation or 5 half–lives, whichever period is longer, prior to the screening visit.
- •Pregnancy or lactation.
- •Any situation that may prevent the test from being performed in accordance with the protocol, or the consent of the investigator to be given in writing, including alcohol, drugs or any other substance overuse or addiction.
- •Severe, symptomatic valve disorder.
- •Urgent hospitalisation for whatever reasons (percutaneous/surgical procedure requiring hospitalisation within 4 weeks prior to randomisation).
- •Body weight <50 kg.
- •Haemoglobin <8 g/dL or >15,5 g/dL.
- •Serum ferritin >400 ng/mL.
- •Active gastroenteral bleeding.
- •Known hypersensitivity to any of the administered preparations.
- •Treatment with erythropoiesis stimulating factors, i.v. iron therapy or blood transfusion within 6 months prior to randomisation.
结局指标
主要结局
1) Time to all-cause death assessed up to maximum 36-months follow-up;
1) Time to all-cause death assessed up to maximum 36-months follow-up;
2) Number of HFE assessed up to maximum 36-months follow-up;
2) Number of HFE assessed up to maximum 36-months follow-up;
3) Time to first HFE assessed up to maximum 36-months follow-up;
3) Time to first HFE assessed up to maximum 36-months follow-up;
4) Changes in serum NT-proBNP concentration from the start of the follow-up to the end of participation in the study assessed as the area under the curve;
4) Changes in serum NT-proBNP concentration from the start of the follow-up to the end of participation in the study assessed as the area under the curve;
5) Changes in quality of life (QoL) measured using the EQ-5D questionnaire from the start of the follow-up to the end of participation in the study assessed as the area under the curve.
5) Changes in quality of life (QoL) measured using the EQ-5D questionnaire from the start of the follow-up to the end of participation in the study assessed as the area under the curve.
次要结局
- First unplanned HF hospitalisation or unplanned visit at emergency department due to HF or CV death during the follow-up (time-to-event model).
- All unplanned HF hospitalisations and unplanned visit at emergency department due to HF and CV death during the follow-up (recurrent event model).
- All unplanned HF hospitalisations and unplanned visit at emergency department due to HF during the follow-up (recurrent event model).
- All unplanned HF hospitalisations during the follow-up (recurrent event model).
- CV death during thefollow-up.
研究者
University Clinical Research Support Center
Scientific
Wroclaw Medical University