Extra energy for hearts with a genetic defect: ENERGY trial
Phase 1
- Conditions
- Hypertrophic cardiomyopathyTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2018-000029-29-NL
- Lead Sponsor
- VU University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Carrier of HCM associated genetic mutation in one of the following genes: Myosin Heavy Chain 7 (MYH7), Myosin Binding Protein C3 (MYBPC3), cardiac muscle Troponin T (TNNT2)
18 - 65 years
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 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Cardiovascular disease
Renal insufficiency GFR <30 ml/min
Younger than 18 years
Older than 65 years
Any absolute or relative contra-indication for MRI (i.e. pacemaker and claustrophobia)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Establish if trimetazidine reverses reduced myocardial efficiency in asymptomatic HCM mutation carriers;Secondary Objective: As impaired relaxation of the heart (i.e. diastolic dysfunction) is present in asymptomatic HCM mutation carriers, in addition to cardiac efficiency, we will study effects of trimetazidine on diastolic cardiac function;Primary end point(s): Second 11C acetate PET/CT-scan and MRI scan ;Timepoint(s) of evaluation of this end point: 2 months after the start of treatment with trimetazidine
- Secondary Outcome Measures
Name Time Method Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable