跳至主要内容
临床试验/NL-OMON25612
NL-OMON25612招募中不适用

TrimetaziDine as a Performance-enhancING drug in Heart Failure with Preserved Ejection Fraction

Amsterdam UMC, location VUmc0 个研究点目标入组 25 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
25

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

入选标准

  • 1. Diagnosis of Heart failure with preserved ejection fraction (HFpEF):
  • a) signs/and or symptoms of heart failure, NYHA II or higher (and ambulant).
  • b) LVEF >50%
  • c) evidence of LV diastolic dysfunction; with the exclusion of other significant co-morbidity (especially other severe cardiac conditions, severe kidney failure, parkinsonism) and able to comply the complete protocol (RHC, MRI/MRS).
  • d. no other significant cardiac (e.g. significant valvular disease) or extra-cardiac condtion (e.g. severe COPD) that explains symptoms.
  • 2. Clinically stable (no change in diuretics >1 month), co-morbidities managed.
  • 3. Informed consent.

排除标准

  • 1.Current acute decompensated heart failure, requiring augmented therapy with intravenous diuretics, vasodilator and/or inotropic drugs;
  • 2.Acute coronary syndrome, TIA/CVA, major surgery within the 3 months prior;
  • 3.Suspected septal scar (e.g. due to myocardial infarction) which prohibits the measurement of PCr/ATP with magnetic resonance spectroscopy (MRS))
  • 4.Unable to undergo the complete study protocol (right heart catheterization, MRI/MRS, 6-MWD)
  • 5.Contra-indication for trimetazidine (severe kidney failure with an eGFR <30ml/min, parkinsonism or patients requiring medication that cause parkinsonism)
  • 6.Doubt about compliance
  • 7.Pre-menopausal women who are nursing, pregnant, or of child-bearing potential and not practicing an acceptable method of birth control
  • 8.Chronic absorption problems
  • 9.Estimated life-expectancy < 1 year.

研究者

发起方
Amsterdam UMC, location VUmc

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