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Extra energy for hearts with a genetic defect: ENERGY trial

Extra energy for hearts with a genetic defect: ENERGY trial - ENERGY

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON52384
Enrollment
40
Registered
2018-11-21
Start date
2019-03-13
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abnormally thick heart muscle disease

Interventions

Trimetazidine 20mg three times daily, or placebo 20mg three times daily

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Carrier of HCM associated genetic mutation in the gene encoding for Myosin Heavy Chain 7 (MYH7), Myosin Binding Protein C3 (MYBPC3) or cardiac muscle Troponin T (TNNT2) 18 - 65 years

Exclusion criteria

Exclusion criteria: Cardiovascular disease (in particular HCM defined by maximum wall thickness >15mm), Parkinson disease or parkinsonian symptoms, Renal insufficiency GFR

Design outcomes

Primary

MeasureTime frame
The difference in mean myocardial energy efficiency after two months of treatment with trimetazidine compared to placebo

Secondary

MeasureTime frame
To study the effect of trimetazidine on: • diastolic function: echocardiography to measure E, A, E/A, E*, E/E* in cm/s • left ventricle and left atrial volume parameters: end-diastolic volume, end-systolic volume, ejection fraction, left ventricular mass, left atrial volume • exercise capacity: duration of exercise, workload • and electrophysiological properties of the heart: ECG to measure PR, QRS, QT interval, ST elevation/depression, heart rate

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)