NL-OMON54927招募中2 期
Pathophysiological relevance of IRON deficiency and related mitochondrial dysfunction in Heart Failure with Preserved Ejection Fraction (IRON-HFpEF) - IRON-HFpEF
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 45
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Diagnosis of heart failure with preserved ejection fraction
- •a. signs/and symptoms of heartfailure (NYHA II or higher)
- •b. Left ventricular ejection fraction >=50%
- •c. evidence of left ventricular diastolic dysfunction:
- •-pulmonary capillary wedge pressure (PCWP) at rest >= 15mmHg and/or PCWP
- •leg-raise >= 20mmHg and/or PCWP during exercise >= 25mmHg
- •or if no right heart catheterisation has been performed:
- •-HFpEf score >= 6;
- •-diastolic dysfunction grade II or higher on echocardiogram + NTproBNP of
- •>125 pg/mL
- •d. no other significant cardiac (e.g. significant valvular disease) or
- •extra-cardiac con-dition (e.g. severe COPD) that explains symptoms
- •2. Optimal medical treatment
- •3. Clinically stable
- •4. Iron deficient (ferritin <100pg/L or ferritin 100-300pg/L and transferrin
- •saturation or TSAT <20%).
- •5. Hemoglobin >9.0 g/dL (5.6 mmol/L)
排除标准
- •1. No informed consent
- •2. Contra indication ferric carboxy maltose
- •a. known allergic reaction to product; b. clinical signs of an acute infection;
- •c. conditions with high risk for an allergic reaction: severe asthma or eczema,
- •systemic lu-pus erhytematosus, rheumatoid arthritis or concurrent use of
- •significant immunosuppres-sive therapy (With an exception of patients who
- •previously have received intravenous iron without allergic response. As
- •allergic reaction is unlikely in these patients).; severe liver disease
- •3. History of (previous 2 months) or planned use of intravenous/oral iron,
- •erythro-poietin or blood transfusion
- •4. Indication for iron supplementation according to Dutch guidelines.
- •5. Acute coronary syndrome, TIA/CVA, PCI/CABG/valve replacement or any major
- •surgery within 3 months prior;
- •6. Unable to undergo the complete study protocol (i.e. right heart
- •catheterisation, 6 minute walk distance)
- •7. Indication for iron supplementation
研究者
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