Adult patients with a cardiac sodium channel gene SCN5A mutation, one variant of the congenital long-QT syndrome, with implantable cardioverter defibrillator (ICD). MedDRA version: 9.1 Level: LLT Classification code 10057926 Term: Long QT syndrome congenital
Conditions
Interventions
Trade Name: OMACOR
Pharmaceutical Form: Capsule, soft
CAS Number: 25378272
Other descriptive name: EICOSAPENTAENOIC ACID
Concentration unit: % percent
Concentration type: equal
Concentration number: 4
Sponsors
Pierre Fabre Médicament
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female gender, • Aged from 18 to 60 years, • LQT3 syndrome genotype confirmed in medical file, • QTc interval more or equal to 470 ms, • Wearing an ICD, • Accepting to participate to the study and able to understand and sign an approved Informed Consent Form, • Able to understand the protocol and to come to the control visits, • Likely to be compliant during the study, according to the judgement of the investigator, • Registered with a social security or health insurance system. For women of child bearing potential: • Use of an efficient contraceptive for at least 2 months before the study and one month after the end of the study, • Negative urine or blood pregnancy test. 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: * Criteria related to pathologies • History of hypersensitivity or intolerance to one of the substances of content of the study drug (EPA ethyl ester, DHA ethyl ester, alpha-tocopherol, gelatin, soya), • Severe hepatic impairment, • High risk of haemorrhage, • Any cardio-vascular, renal, gastro-intestinal, endocrine, haematological, neuro-psychiatric disease that will not be compatible with the participation to the study in the opinion of the investigator, • Any acute or chronic disease that will not allow with the participation to the study in the opinion of the investigator. * Criteria related to treatments • Use of any medication that prolongs QT interval. The list of the Drugs to be Avoided by Patients with Congenital Long QT Syndrome is detailed on web site: www.QTdrugs.org (see appendix 17.2) • Use of food complements enriched in n-3 PUFAs in the last 2 weeks. * Criteria related to the way of life Consumption of n-3 PUFAs rich foods (fat fishes, soya, colza and nut oils) > 3 times/week. * Criteria related to the population • Participation to another clinical study in the previous month or during the study or planning to participate to another clinical study within one month after the present study, • Forfeited freedom by administrative or legal award, or under guardianship, • Who cannot be contacted in case of emergency, • Who planned travel outside the study area for a substantial portion of the study period. For women of childbearing potential: • Pregnancy, • Breast-feeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of Omacor on the electrocardiographic QTc Fridericia interval in LQT3 patients (cardiac sodium channel gene SCN5A mutation leading to congenital long-QT syndrome).;Secondary Objective: To assess the effect of Omacor® on: - the T wave morphology, - the standard ECG parameters: RR interval, QRS complex, PR interval, - the relationship between the QTc Fridericia interval and the erythrocyte cellular membrane and cheek cells concentration in PUFAs. ;Primary end point(s): The main criterion is defined as the modification of the QT interval corrected for heart rate (QTc) using the Fridericia equation after 6 weeks of treatment. | — |
Countries
France
Outcome results
None listed