Extra energy for hearts with a genetic defect: ENERGY trial

Phase 2

Completed

Conditions: Abnormally thick heart muscle disease
10028593

Registration Number: NL-OMON52384

Lead Sponsor: Vrije Universiteit Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

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

Cardiovascular disease (in particular HCM defined by maximum wall thickness
>15mm), Parkinson disease or parkinsonian symptoms, Renal insufficiency GFR <60
ml/min, Any absolute or relative contra-indication for MRI (i.e. pacemaker and
claustrophobia), pregnancy, diabetes mellitus, chronic use of systemic
medication (except oral contraception)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The difference in mean myocardial energy efficiency after two months of<br /><br>treatment with trimetazidine compared to placebo</p><br>

Secondary Outcome Measures

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