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临床试验/NL-OMON52482
NL-OMON52482招募中不适用

Oxidative skeletal muscle metabolism in chronic heart failure patients with and without iron deficiency - Oxidative exercise capacity in chronic HF with and without ID

niversitair Medisch Centrum Groningen0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
18 至 99(—)

入选标准

  • For HFrEF patients:
  • - Diagnosis of chronic HF of either ischemic or non-ischemic etiology;
  • - Stable, evidence-based medical therapy for HF;
  • - LVEF <40% measured <5 year prior to inclusion;
  • - NYHA class II - III (symptomatic HF) at moment of inclusion;
  • For HFpEF patients:
  • - Diagnosis of chronic HF of either ischemic or non-ischemic etiology;
  • - LVEF >40% measured <5 year prior to inclusion;
  • - Left atrial volume index (LAVI) >34 mL/m2 or left ventricular mass index >=115
  • g/m2 (for males) or >=95 g/m2 (for females) or E/e* >=13 or mean e* (septal and
  • lateral) <9 cm/s, as measured on echocardiography <1 year prior to inclusion;
  • - NYHA class II - III (symptomatic HF) at moment of inclusion;
  • - Serum NT-proBNP >=125 pg/mL when in sinus rhythm; >300 pg/mL when in atrial
  • fibrillation.
  • Additional inclusion criterion for subjects with ID:
  • - Iron deficiency, defined as TSAT <20%.
  • For control subjects:
  • - No diagnosis of heart failure
  • - No diagnosis of severe vascular or (neuro-)muscular disease

排除标准

  • - Age <18 years
  • - Unable or unwilling to undergo exercise MRI (e.g. pregnancy, physical
  • disabilities, claustrophobia)
  • - The presence of ferromagnetic material in/on the body which cannot be removed
  • (e.g. non-MRI-compatible cardiac devices, tattoos containing ferrous ink)
  • - History of erythropoietin stimulating agent, intravenous iron therapy and/or
  • blood transfusion <3 months prior to study enrolment
  • - Moderate anaemia, defined as Hb <7 mmol/L for both men and women
  • - Oral iron therapy >100 mg/day <4 weeks prior to study enrollment
  • - Unable to understand study procedures
  • - Unable or unwilling to provide informed consent

研究者

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