Effect and Safety of Flecainide and Metoprolol Versus Metoprolol Alone to Suppress Ventricular Arrhythmias in Arrhythmic Mitral Valve Prolapse

Launched by OSLO UNIVERSITY HOSPITAL · Nov 16, 2022

Keywords

ClinConnect Summary

The FLECAPRO trial is studying how well a medication called flecainide works when added to standard treatment with metoprolol for patients with mitral valve prolapse and heart rhythm problems known as ventricular arrhythmias. The goal is to see if combining these two medications can better reduce these irregular heartbeats compared to using metoprolol alone. Participants will have their heart activity monitored using a small device implanted under the skin to track their arrhythmias accurately during the study.

To join this trial, individuals need to be at least 18 years old and have been diagnosed with mitral valve prolapse and ventricular arrhythmias. They should also have a doctor’s recommendation for antiarrhythmic treatment. Participants can expect regular check-ups and monitoring throughout the trial. It's important to note that certain health conditions and medications may prevent someone from being eligible, so a thorough screening will be done. Women who can become pregnant will need to use birth control during the study and for a short time after. Overall, this trial aims to find safer and more effective treatment options for people with this heart condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• • Participants must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).
• • Participants (only women of childbearing) must accede to mandatory use of a contraceptive method for the duration of the trial and until 3 days after discontinuation of study medication.
• Exclusion Criteria:
• • 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
• • Ion channelopathy, including Brugada syndrome and long QT syndrome
• • Genetic cardiomyopathy (hypertrophic cardiomyopathy, arrhythmogenic cardiomyopathy, dilated cardiomyopathy, including genotype positive phenotype negative individuals)
• • Atrial flutter or permanent atrial fibrillation
• • Sinus node dysfunction
• • Ongoing electrolyte disorders
• • More than moderate valvular disease according to international guidelines
• • Pre-excitation
• • Any degree of AV-block, except due to enhanced vagal tone (e.g. Wenckebach-block at night in young athletes or 1st-degree AV block that disappears during exercise)
• • Bundle branch block (QRS duration \>120 ms) or intraventricular conduction defect with QRS \>120 ms.
• • Prior flecainide therapy.
• • Concomitant use of the following medications (i) CYP2D6 inhibitors/inducers, (ii) class I, III or IV antiarrhythmic drugs, (iii) clozapine, quinidine, cimetidine, bupropion, or (iii) monoamineoxidase (MAO) inhibitors
• • Pregnancy
• • Not willing to use a mandatory contraceptive method for the duration of the trial.