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

VU University Medical Center (VUmc)0 个研究点目标入组 25 人开始时间: 2019年1月22日最近更新: 2022年3月2日

适应症

试验速览

暂无简介。

•In order to be eligible to participate in this study, a subject must meet all of the following criteria:
•1.Diagnosis of HFpEF:
•a.signs/and or symptoms of heart failure, NYHA II or higher (and ambulant)
•b.LVEF = 50% (by any modality)
•c.evidence of LV diastolic dysfunction (PCWP at rest >15mmHg and/or PCWP during exercise = 25mmHg; diastolic dysfunction grade II or higher with a NT-proBNP level >125 pg/mL) [1,23,32]
•d.no other significant cardiac (e.g. significant valvular disease) or extra-cardiac condition (e.g. severe COPD) that explains symptoms
•2.Clinically stable (no change in diuretic for >1 month), co-morbidities managed
•3.Informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 3
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 22

•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 ratio with MRS;
•4. Unable to undergo the complete study protocol (RHC, MRI/MRS, 6MWD);
•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.

发起方

VU University Medical Center (VUmc)