Effects of Flecainide on Cardiac Arrhythmias in ARVC Patients
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Arrhythmogenic Right Ventricular Cardiomyopathies
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Age: Between 18 years - 100 years
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Gender: Male or Female
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Other Inclusion Criteria:
- Subjects who have been diagnosed with ARVC and meet 2010 Modified Task Force Criteria for ARVC as affected.
- Subjects with at minimum 500 VPBs on the most recent 24-hour Holter monitor recording prior to consent or after consent if a subsequent recording is required after 5 day washout following discontinuation of anti-arrhythmic medication.
- Subjects with functioning implanted cardioverter defibrillator with remote interrogation capability.
- Subjects should be on a beta-blocker including metoprolol, propranolol, atenolol, nadolol, carvedilol or bisoprolol unless contraindication to beta-blockers exists.
- Persons prescribed quinidine, procainamide, propafenone, disopyramide, dronedarone phenytoin, mexilitene, may be included after 5 day washout period with subsequent 24- hour Holter obtained after washout period
- Persons prescribed sotalol may be included after 5 day washout period during which another beta-blocker may be administered with subsequent 24-hour Holter obtained.
- Subject and personal physician and or cardiologist must agree not to use any antiarrhythmic medications during the 10 weeks of participation, unless needed for management of life-threatening arrhythmias
- All subjects must agree to use medically acceptable contraceptive measures during participation unless documented as surgically sterile or post-menopausal (no menstrual periods for more than one year).
You may not be eligible for this study if the following are true:
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- Subjects who prescribed amiodarone or dofetilide at the time of consent.
- Subjects with left ventricular ejection fraction =40% by any imaging modality: echocardiography, angiography, CMRI, or cardiac nuclear test on the most recent test.
- Subjects with NYHA heart failure class III or IV at time of consent.
- Subjects with prior myocardial infarction at any time in the past.
- Subjects who are pacemaker dependent rhythm at the time of consent.
- Subjects with renal impairment (GFR <30 mL/min/m2).
- Subjects wtih prior diagnosis of severe hepatic impairment.
- Subjects who are pregnant or plan to become pregnant
- Subjects who are participating in any other interventional clinical trial.
- Subjects unwilling or unable to cooperate with the protocol
- Subjects who lives at such a distance from the clinic that travel for the consent visit would be unusually difficult
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.