Pilot Randomized Trial With Flecainide in ARVC Patients
Completed · Phase 2 · Has a placebo group
Conditions studied: Arrhythmogenic Right Ventricular Cardiomyopathy
In brief
Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC) is an inherited arrhythmia disorder with high risk of ventricular tachycardia or fibrillation, and implantable cardioverter defibrillator remains as therapy of choice. Antiarrhythmic therapy with different agents including beta-blockers, sotalol and amiodarone are usually not effective in reducing risk of arrhythmic events. Recent data indicated that flecainide effectively prevented the arrhythmias observed in the experimental ARVC animals and in small series of ARVC patients. These observations provide a strong rationale for conducting a pilot randomized clinical trial to determine whether flecainide will reduce ventricular arrhythmias in high-risk ARVC patients. This pilot study is designed as randomized double-blinded placebo-controlled crossover trial with administration of 100 mg of Flecainide or matching placebo twice a day for 4 weeks each with a washout period. Primary specific aim of this pilot trial is to determine whether Flecainide administration is associated with a significant reduction of number of ventricular ectopic beats (VEBs) in ARVC patients with implantable cardioverter-defibrillator (ICD).
Key facts
- Study ID
- NCT03685149
- Run by
- University of Rochester
- People needed
- 22
- Starts
- 2019-07-23
- Expected to finish
- 2022-07-31
- Last updated by the study team
- 2024-08-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age > 18 years.
- Subjects who have been diagnosed with ARVC and meet 2010 Modified Task Force Criteria for ARVC as affected.
- At minimum 500 VEBs 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.
- 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, mexiletene, flecainide, may be included after 5 day washout period with subsequent 24 Hour Holter obtained after washout period.
- Persons prescribed sotalol must 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 qualify if…
- Prescribed amiodarone or dofetilide at the time of consent.
- Left ventricular ejection fraction ≤40% by any imaging modality: echocardiography, angiography, cardiac magnetic resonance imaging (CMRI), or cardiac nuclear test on the most recent test.
- New York Heart Association (NYHA) heart failure class III or IV at time of consent.
- Prior myocardial infarction at any time in the past.
- Pacemaker dependent rhythm at the time of consent.
- Renal impairment (GFR <30 mL/min/m2).
- Prior diagnosis of severe hepatic impairment.
- Pregnant or plan to become pregnant during the course of the trial (Flecainide has not been adequately studied in pregnant women). Pregnancy test is required for women of child-bearing potential prior to randomization.
- Participating in any other interventional clinical trial.
- Unwilling or unable to cooperate with the protocol.
- Lives at such a distance from the clinic that travel for the consent visit would be unusually difficult.
- Decisionally impaired adults, those of questionable capacity, those who cannot manage taking the study drug per the prescribed regimen, and those who cannot consent for themselves will not be recruited for this study.
- Unwilling to sign the consent for participation.
Where it is running
- University of Colorado — Denver, Colorado, United States
- John Hopkins University — Baltimore, Maryland, United States
- New York University — New York, New York, United States
- University of Rochester Medical Center — Rochester, New York, United States
- Duke University — Durham, North Carolina, United States
- University of Pensylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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