NL-OMON48659CompletedPhase 2
TrimetaziDine as a Performance-enhancING drug in Heart Failure with Preserved Ejection Fraction - DoPING-HFpEF
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 30
Study Overview
Brief Summary
Trial is onging in other countries
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Investigators
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