TrimetaziDine as a Performance-enhancING drug in Heart Failure with Preserved Ejection Fractio
- Conditions
- Heart failure with preserved ejection fraction (HFpEF)Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2018-002170-52-NL
- Lead Sponsor
- VU University Medical Center (VUmc)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 25
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Assess the effect of a 3-month trimetazidine treatment in patients with HFpEF on LV diastology (change in exercise PCWP measured by exercise right heart catheterization or RHC);Secondary Objective: Assess the effect of a 3-month trimetazidine treatment in patients with HFpEF on myocardial energy content (PCr/ATP-ratio measured by 31P-MR spectroscopy);Primary end point(s): Exercise PCWP measured by RHC (gold standard for the evaluation of LV diastology);Timepoint(s) of evaluation of this end point: 3 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Myocardial PCr/ATP-ratio measured by 31P-MRS;Timepoint(s) of evaluation of this end point: 3 months