EUCTR2017-004667-13-GB进行中（未招募）1 期
Effect of Iron (III) Isomaltoside 1000 on Cardiac Energetics in Anaemic and Non-anaemic Patients with Symptomatic Chronic Heart Failure and Iron Deficiency: The Ferric Iron in Heart Failure (FERRIC-HF) III Trial - Ferric Iron in Heart Failure (FERRIC-HF) III Trial
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 64
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Aged 18 to 89 years
- •Ferritin <100 mcg/l or Ferritin 100 – 300 mcg/l with TSAT <20%
- •Anaemic group (50% of study population): Hb <120 g/L in Females and Hb <130 g/L in Males
- •Non-anaemic group (50% of study population): Hb =120 g/L in Females and =130 g/L in Males
- •Stable New York Heart Association (NYHA) class II-IV symptoms for the preceding 4 weeks
- •LVEF = 45% assessed by Echocardiography or Cardiac MRI within the preceding 6 months
- •On optimally tolerated heart failure drugs for = 4 weeks with no changes (dose or medication type) for the preceding 2 weeks
- •Resting blood pressure = 160/100mmHg
- •Negative pregnancy test in premenopausal females.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 32
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 32
排除标准
- •Inability to provide written informed consent
- •Inability to sufficiently understand information pertaining to the conduct of the trial
- •Contraindications to 31P-MRS (e.g. pacemaker, metal prosthesis, etc)
- •Ischaemic cardiomyopathy
- •Folate and vitamin B12 levels below laboratory normal limit.
- •Use of erythropoietic agent, blood transfusion or immunosuppressive therapy in the preceding 30 days, or ongoing anticipated need for these agents during the study.
- •Acute or chronic bleeding, infective or inflammatory disorders (Rheumatoid Arthritis, Lupus, HIV/AIDS, malignancy, etc.)
- •History of iron overload or haemochromatosis in patient or first degree relatives.
- •Prior intolerance to intravenous iron formulations or any of their excipients
- •Chronic liver disease and/or aspartate transaminase (AST) >3 times the upper limit of the normal range
- •Renal dialysis (Haemodialysis or peritoneal dialysis)
- •Severe asthma or any severe lung disease with FEV1<50% of predicted or necessitating domicillary oxygen or non-invasive ventilation.
- •Severe atopic disorder including eczema or any prior anaphylactoid / anaphylactic reaction.
- •Haemolytic or myelodysplastic anaemia
- •Severe uncorrected non-functional valvular disease or left ventricular outflow obstruction, obstructive cardiomyopathy, uncontrolled fast atrial fibrillation or flutter (>110 bpm), uncontrolled symptomatic brady- or tachyarrhythmias.
- •Musculoskeletal limitation that, in the investigators judgement, would impair exercise testing.
- •Pregnant or breast feeding
- •Contemporaneous enrolment in another clinical trial
研究者
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