NL-OMON21811招募中不适用
Effect of Iron Deficiency on skeletal muscle metabolism in HFpEF
Vifor pharma0 个研究点目标入组 78 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 78
研究概览
简要总结
one
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •Group I HFpEF with iron deficiency
- •Group II HFpEF without iron deficiency
- •HFpEF: according to the ESC guidelines
- •(1) Signs and/or symptoms of heart failure,
- •(2) LVEF = 50%,
- •(3) Elevated levels of natriuretic peptide (NT-proBNP > 125 pg/ml
- •~ 15 pmol/L)
- •(4) one of the following additional criteria
- •a)Relevant structural heart disease; LV hypertrophy, (LVmass index > 95 g/m2 in women, or >115 g/m2 in men) and/or LA enlargement (LA volume index >34 l/m2)
- •b)Diastolic dysfunction (E/e’ = 13, mean e’ septal and lateral wall < 9 cm/s)
- •Iron deficiency: serum ferritin < 100 µg/L or serum ferritin between 100-299 µg/L in combination with a transferrin saturation < 20%.
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •-Reproductive age women
- •-Any iron supplement (oral, iv) during the last 6 months prior to inclusion
- •-Any chemotherapy in last year
- •-Significant peripheral artery disease
- •-Contraindication for CMR
- •ODIN protocol:
- •Uitvoering van MRI onderzoek bij patiënten met een cardiaal implanteerbaar elektronisch device (CIED), waaronder een pacemaker en ICD”
- •ODIN protocol:
- •Voorbereiding klinische patiënten voor MRI onderzoek”
- •Metallic implant (vascular clip, neuro-stimulator, cochlear implant)
- •Pacemaker or implantable cardiac defibrillator(ICD)
- •Claustrophobia
- •-Body weight > 130kg
研究者
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