TrimetaziDine as a Performance-enhancING drug in Heart Failure with Preserved Ejection Fractio
- Conditions
- heart failure with preserved ejection fractiondiastolic heart failure10019280
- Registration Number
- NL-OMON48659
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
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. LV ejection fraction * 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 (echocardiography) with a NT-proBNP level >125 pg/mL)
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
A potential subject who meets any of the following criteria will be excluded from participation in this study:
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 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/1.73m2, 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 <p>exercise PCWP measured by RHC</p><br>
- Secondary Outcome Measures
Name Time Method <p>Key secondary endpoint: myocardial PCr/ATP-ratio measured by 31P-MRS<br /><br>Safety endpoint: (S)AE; Metabolic: trimetazidine plasma levels, mitochondrial<br /><br>function, insulin resistance (HOMA)<br /><br>Exploratory: NT-proBNP, 6MWD, quality-of-life (KCCQ, EQ-5D).</p><br>