ACTRN12620000285954招募中4 期
A double-blind, randomised, placebo-controlled study to assess the effects of intravenous ferric carboxymaltose on exercise tolerance in patients with atrial fibrillation and iron deficiency.
niversity of Adelaide0 个研究点目标入组 84 人开始时间: 2020年3月3日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 84
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •At least 18 years of age
- •Paroxysmal or persistent atrial fibrillation
- •Stable medical therapy in the 4 weeks prior to enrolment with no dose changes of atrial fibrillation drugs in the last 2 weeks
- •Haemoglobin < 150g/L
- •Serum ferritin < 100 ug/L or serum ferritin < 300 ug/L if Tsat < 20%
排除标准
- •Known hypersensitivity to parenteral iron preparations
- •History of primary or secondary haemochromatosis
- •Known haemoglobinopathy or haemolytic anaemia
- •History of erythropoietin-stimulating agent, intravenous iron therapy, and / or blood transfusion in the 6 weeks prior to randomisation
- •Requiring treatment with blood transfusion in the next 3 months
- •Requiring surgery with anticipated moderate or severe blood loss in the next 3 months
- •Oral iron therapy at doses > 80 mg/day (of elemental iron) in the 1 week prior to randomisation (note: ongoing use of multivitamins containing <= 80 mg/day is permitted)
- •Planned cardioversion, catheter ablation, AV nodal ablation with pacemaker insertion or surgical ablation within the next 3 months
- •Body weight <= 35 kg
- •Exercise training program(s) in the 3 months prior to screening, or planned in the next 3 months
- •Ongoing blood loss
- •Current active autoimmune or systemic inflammatory diseases
- •Current active systemic infection or bacteraemia
- •Known chronic liver disease, hepatitis B or hepatitis C infection, or screening AST / ALT above three times the upper limit of normal range
- •Known active malignancy, with the exception of squamous cell and basal cell carcinoma of the skin, and cervical intraepithelial neoplasia
- •Currently receiving systemic chemotherapy and/or radiotherapy
- •Known chronic kidney disease
- •History of dialysis, current dialysis or dialysis planned within the next 3 months
- •Currently pregnant, breastfeeding, or trying to conceive within the next 3 months
- •Acute myocardial infarction, transient ischaemic attack, or stroke in the 3 months prior to randomisation
- •Coronary artery bypass graft, percutaneous intervention, or major surgery (including thoracic and cardiac surgery) within the last 3 months (diagnostic catheterisations are allowed)
- •Subject is unable to perform exercise testing, either according to the Investigator’s judgement, or due to the following conditions:
- •o Severe lower limb musculoskeletal or neurological conditions
- •o Unstable angina
- •o Severe valvular or left ventricular outflow tract obstruction requiring intervention
- •Subject is currently enrolled in, or is within 30 days of completion of, another interventional study
- •Subject has previously been randomised to this study (subjects may be rescreened if they previously did not meet the eligibility criteria)
- •Subject will not be available for completion of all assessments as per the study protocol
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