ISRCTN16403302已完成4 期
Effectiveness of intravenous iron treatment vs standard care in patients with heart failure and iron deficiency: a randomised, open-label multicentre trial (IRONMAN)
niversity of Glasgow0 个研究点目标入组 1,137 人开始时间: 2016年12月15日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,137
研究概览
简要总结
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36347265/ (added 08/09/2023)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 31/05/2018:
- •1. Aged =18 years
- •2. LVEF <45% within the prior two years using any conventional imaging modality (this should be the most recent assessment of LVEF)
- •3. New York Heart Association (NYHA) class II – IV
- •4. Iron deficient - defined as TSAT <20% and/or ferritin <100 mcg/l
- •5. Evidence of being in a higher risk HF group:
- •5.1. Current (with the expectation that patient will survive to discharge) or recent (within 6 months) hospitalisation for HF (as of 08/10/2018), or
- •5.2. Out-patients with NT-proBNP >250 ng/l in sinus rhythm or >1,000 ng/l in atrial fibrillation (or BNP of >75 pg/ml or 300 pg/ml, respectively)
- •6. Able and willing to provide informed consent
- •Previous inclusion criteria:
- •1. Age =18 years
- •2. LVEF <45% within the last 6 months using any conventional imaging modality
- •3. New York Heart Association (NYHA) class II – IV
- •4. Iron deficient defined as a TSAT<20% and/or ferritin >100 mcg/l
- •5. Evidence of being in a higher risk heart failure group:
- •5.1. Current (with intention to discharge in next 48 hours) or recent (within 6 months) hospitalisation for heart failure, or
- •5.2. Outpatients with NTproBNP >250 ng/l in sinus rhythm or >1,000 ng/l in atrial fibrillation (or BNP of > 75 pg/ml or 300 pg/ml, respectively)
- •6. Able and willing to provide informed consent
排除标准
- •Current exclusion criteria as of 31/12/2019:
- •1. Haematological criteria: ferritin >400ug/l; haemoglobin <9.0, or >13 g/dl in women or >14 g/dl in men; (B12 or folate deficiency should be corrected but do not exclude the patient)
- •2. MDRD/CKD-EPI estimated glomerular filtration rate (eGFR) <15ml/min/1.73m²
- •3. Already planned to receive IV iron
- •4. Likely to need or already receiving erythropoiesis stimulating agents (ESA)
- •5. Any of the following apply:
- •5.1. Planned cardiac surgery or revascularisation
- •5.2. Within 3 months of any of the following: a primary diagnosis of type 1 myocardial infarction (excluding small troponin elevations in the context of heart failure admissions), cerebrovascular accident (CVA), major CV surgery or percutaneous coronary intervention (PCI), or blood transfusion
- •5.3. On active cardiac transplant list
- •5.4. Left ventricular assist device implanted
- •6. Any of the following comorbidities: active infection (if the patient is suffering from a significant ongoing infection as judged by the investigator recruitment should be postponed until the infection has passed or is controlled by antibiotics), other disease with life expectancy of <2 years, active clinically relevant bleeding in the investigator’s opinion, known or suspected gastro-intestinal malignancy
- •7. Pregnancy, women of childbearing potential (i.e. continuing menstrual cycle) not using effective contraception or breast-feeding women
- •8. Contraindication to IV iron in the investigator’s opinion according to current approved Summary of Product Characteristics:
- •8.1. Hypersensitivity to the active substance, to Monofer® or any of its excipients (water for injections, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment))
- •8.2. Known serious hypersensitivity to other parenteral iron products
- •8.3. Non-iron deficiency anaemia (e.g. haemolytic anaemia)
- •8.4. Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis, haemosiderosis)
- •8.5. Decompensated liver disease
- •9. Participation in another intervention study involving a drug or device within the past 90 days (co-enrolment in observational studies is permitted)
- •______
- •Previous exclusion criteria as of 08/10/2018:
- •1. Haematological criteria: ferritin >400ug/l; haemoglobin <9.0, or >13 g/dl in women or >14 g/dl in men; (B12 or folate deficiency should be corrected but do not exclude the patient)
- •2. MDRD estimated glomerular filtration rate (eGFR) <15ml/min/1.73m2
- •3. Already planned to receive IV iron
- •4. Likely to need or already receiving erythropoiesis stimulating agents (ESA)
- •5. Any of the following apply:
- •5.1. Planned cardiac surgery or revascularisation
- •5.2. Within 3 months of any of the following: a primary diagnosis of type 1 myocardial infarction (excluding small troponin elevations in the context of heart failure admissions), cerebrovascular accident (CVA), major CV surgery or percutaneous coronary intervention (PCI), or blood transfusion
- •5.3. On active cardiac transplant list
- •5.4. Left ventricular assist device implanted
- •6. Any of the following comorbidities: active infection (if the patient is suffering from a significant ongoing infection as judged by the investigator recruitment should be postponed until the infection has passed or is controlled by antibiotics), other disease with life expectancy of <2 years, active clinically relevant bleeding in the investigator’s opinion, known or suspected gastro-intestinal malignancy
- •7. Pregnancy, women of childbearing potent
研究者
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