No registrations found.
ID
Source
Brief title
Health condition
Hypertrophic Cardiomyopathy
Sponsors and support
Intervention
Outcome measures
Primary outcome
Myocardial energy efficiency, as measured by PET/CT and CMR
Secondary outcome
Diastolic function measured by echocardiography, volume parameters of the heart measured by CMR, exercise capacity measured by CPET, electrophysiological properties of the heart measured by ECG
Background summary
Aims: Previous studies have shown that HCM mutation carriers have a decreased myocardial energy efficiency, which is thought to play a key role in the pathomechanism of HCM. The ENERGY trial aims to determine whether metabolic drugs correct decreased myocardial energy efficiency in HCM mutation carriers at an early disease stage.
Methods: 40 genotype-positive, phenotype-negative MYH7 mutation carriers will be treated for two months with trimetazidine or placebo in a double-blind randomized study design. Directly before and after treatment, study subjects will undergo an [11C]-acetate PET/CT and CMR scan to measure myocardial energy efficiency. Myocardial efficiency will be calculated as the amount of oxygen used by the heart to perform work.
Conclusion: The ENERGY trial will be the first proof-of-concept to determine whether metabolic drugs are a potential preventive therapy for HCM. Given that trimetazidine is already used in clinical practice, there is large potential to swiftly implement this drug in HCM therapy.
Study objective
Trimetazidine improves myocardial energy efficiency in MYH7 mutation carriers
Study design
Last patient last visit
Intervention
Trimetazidine 20mg 3dd
Beau van Driel
+31620673492
b.vandriel@vumc.nl
Beau van Driel
+31620673492
b.vandriel@vumc.nl
Inclusion criteria
18-65 years old
Class 5 MYH7 mutation identified by pre-symptomatic genetic screening
Exclusion criteria
Cardiovascular disease
- Hypertrophic Cardiomyopathy (Maximal Wall Thickness >15mm)
- Wall motion disorders
Diabetes mellitus
Any absolute or relative contra-indication for MRI (i.e. metallic implants and claustrophobia)
Inability to give informed consent.
Severely impaired renal function with a GFR < 30 ml/min
Parkinson disease and related symptoms
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7492 |
| Other | METC VUmc : 2018.344 |