TrimetaziDine as a Performance-enhancING drug in Heart Failure with Preserved Ejection Fractio
- Conditions
- Heart failure with preserved ejection fraction
- Registration Number
- NL-OMON25612
- Lead Sponsor
- Amsterdam UMC, location VUmc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 25
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Exercise pulmonary capillary wedge pressure (PCWP) measured by right heart catheterisation
- Secondary Outcome Measures
Name Time Method Key secondary endpoint: myocardial PCr/ATP-ratio measured by 31P-MRS; <br>Safety endpoint: (S)AE; Metabolic: trimetazidine plasma levels, mitochondrial function, insulin resistance (HOMA); Exploratory: NT-proBNP, 6MWD, quality-of-life (KCCQ, EQ-5D).