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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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2 May 2022 |
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Main ID: |
EUCTR2018-000029-29-NL |
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Date of registration:
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11/12/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Extra energy for hearts with a genetic defect: ENERGY trial
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Scientific title:
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Extra energy for hearts with a genetic defect: ENERGY trial - ENERGY |
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Date of first enrolment:
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11/12/2018 |
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Target sample size:
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40 |
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Recruitment status: |
Authorised-recruitment may be ongoing or finished |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-000029-29 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Jolanda van der Velden
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Address:
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de Boelelaan 1118
1081 HV
Amsterdam
Netherlands |
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Telephone:
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Email:
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j.vandervelden@vumc.nl |
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Affiliation:
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VU University Medical Center |
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Name:
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Jolanda van der Velden
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Address:
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de Boelelaan 1118
1081 HV
Amsterdam
Netherlands |
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Telephone:
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Email:
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j.vandervelden@vumc.nl |
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Affiliation:
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VU University Medical Center |
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Key inclusion & exclusion criteria
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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)
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Hypertrophic cardiomyopathy
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Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
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Intervention(s)
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Trade Name: Vastarel
Product Name: Vastarel
Pharmaceutical Form: Capsule, soft
Pharmaceutical form of the placebo: Capsule, soft
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Timepoint(s) of evaluation of this end point: 2 months after the start of treatment with trimetazidine
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Primary end point(s): Second 11C acetate PET/CT-scan and MRI scan
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Main Objective: Establish if trimetazidine reverses reduced myocardial efficiency in asymptomatic HCM mutation carriers
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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
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Secondary Outcome(s)
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Secondary end point(s): not applicable
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Timepoint(s) of evaluation of this end point: not applicable
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Source(s) of Monetary Support
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ZonMW/Heart Foundation
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Ethics review
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Status: Approved
Approval date: 21/11/2018
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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