FLECAPRO is a randomized controlled crossover trial assessing the effect and safety of adding flecainide to standard beta-blocker therapy to reduce the burden of ventricular arrhythmias in patients with arrhythmic mitral valve prolapse. The primary endpoint of will be assessed using an implantable loop recorder with blinded endpoint adjudication.
Participants must be 18 years of age or older at the time of signing the informed consent.
Participants must have mitral valve prolapse evident by echocardiography or cardiac magnetic resonance imaging, defined as more than or equal to 2 mm atrial displacement of any part of the mitral leaflets.
Participants must have ventricular arrhythmias, defined as at least one of the following (i) premature ventricular complex burden ≥3% per 24 hours by Holter monitoring, (ii) premature ventricular complex burden ≥1% per 24 hours if multifocal or occurring in bi-/trigemini and/or couplets by Holter monitoring, (iii) sustained or non-sustained ventricular tachycardia, (iv) aborted cardiac arrest.
Participants must have a clinical indication for antiarrhythmic treatment due to ventricular arrhythmias.
Strict contraindications to flecainide or metoprolol use
Heart failure (signs or symptoms, elevated N-terminal proBNP)
Abnormal liver or kidney function (Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) three times upper normal, estimated glomerular filtration (eGRF) <60)
Prior myocardial infarction or ischemic heart disease
Crossover
Flecainide
DrugFlecainide is mainly used for pharmacological conversion in patients with atrial tachyarrhythmias and to suppress ventricular arrhythmias in patients with structurally normal hearts.
Metoprolol
DrugMetoprolol is a beta-blocker and class II antiarrhythmic drug considered standard care in most cardiac diseases predisposing to ventricular arrhythmias, including arrhythmic mitral valve prolapse.
Number of ventricular tachyarrhythmias
Sum of ventricular fibrillation and ventricular tachycardia (broad complex tachycardia with heart rate \>140/min) on implantable loop recorder during 12 months. Intention-to-treat, superiority.
Burden of premature ventricular complexes
First hierarchical key secondary outcome. Assessed by 24-hour Holter monitoring. Intention-to-treat, superiority
Change in health-related quality of life
Second hierarchical key secondary outcome. Number of patients with ≥5-point increase in Short Form 36 overall summary score. Intention-to-treat, superiority
Number of severe ventricular tachycardias
Third hierarchical key secondary outcome. Sum of (i) non-sustained ventricular tachycardia with syncope, (ii) sustained ventricular tachycardia and (iii) ventricular fibrillation. Intention-to-treat, superiority
Safety composite
Sum of (i) number of adverse events, (ii) number of serious adverse events, and (iii) higher degree atrioventricular (AV)-block (Mobitz type 2 or 3rd-degree AV-block). Safety population.
Number of ventricular tachycardias
Exploratory outcome of the individual component of the primary endpoint. Ventricular tachycardia (broad complex tachycardia with heart rate \>140/min) on implantable loop recorder during 12 months.
Number of ventricular fibrillations
Exploratory outcome of the individual component of the primary endpoint. Ventricular fibrillations on implantable loop recorder during 12 months.
Burden of premature ventricular complexes
Exploratory outcome of the individual component of key secondary endpoints. Assessed by 24-hour Holter monitoring
Health-related quality of life
Exploratory outcome of the individual component of key secondary endpoints. Number of patients with ≥5-point increase in Short Form 36 overall summary score.
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Oslo University Hospital
Lead sponsor
The Research Council of Norway
Collaborator
University of Oslo
Collaborator
