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
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