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
Oslo University Hospital
Lead sponsor
The Research Council of Norway
Collaborator
University of Oslo
Collaborator