Actively Recruiting
Effect and Safety of Flecainide and Metoprolol Versus Metoprolol Alone to Suppress Ventricular Arrhythmias in Arrhythmic Mitral Valve Prolapse
Led by Oslo University Hospital · Updated on 2025-07-30
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
O
Oslo University Hospital
Lead Sponsor
T
The Research Council of Norway
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effect and safety of adding flecainide to standard beta-blocker therapy to reduce ventricular arrhythmias in patients with arrhythmic mitral valve prolapse, a condition where the mitral valve bulges into the left atrium and can cause dangerous heart rhythms. This phase 3 randomized controlled crossover trial addresses the lack of proven treatments for patients who often experience sudden cardiac death or severe symptoms despite current therapies. The study is sponsored by Oslo University Hospital and aims to determine if combining flecainide with metoprolol is better than metoprolol alone for suppressing these arrhythmias. Participants will receive two treatment regimens in a crossover design: one with flecainide added to metoprolol, and one with metoprolol alone. Flecainide is dosed starting at 50 mg twice daily, increasing to a target of 100 mg twice daily, not exceeding 300 mg daily. Metoprolol doses are adjusted based on prior use and patient needs, up to 200 mg daily, given once or twice daily depending on the formulation and preference. The first flecainide dose is given in-hospital with heart monitoring to ensure safety. Dosages are titrated during a run-in period to maximum tolerated levels. Participants will be monitored over 12 months with implantable loop recorders to track ventricular arrhythmias, alongside assessments of premature ventricular complexes, severe ventricular tachycardias, quality of life, and safety. The study uses blinded endpoint adjudication to ensure objective evaluation of arrhythmia burden. This careful monitoring includes regular ECGs and clinical assessments to evaluate how well the treatments suppress arrhythmias and affect patients' well-being over time.
CONDITIONS
Brief Title
Effect and Safety of Flecainide and Metoprolol Versus Metoprolol Alone to Suppress Ventricular Arrhythmias in Arrhythmic Mitral Valve Prolapse
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 2 mm or more atrial displacement of any part of the mitral leaflets.
- Participants must have ventricular arrhythmias, defined as at least one of the following: premature ventricular complex burden �3% per 24 hours by Holter monitoring; premature ventricular complex burden �1% per 24 hours if multifocal or occurring in bi-/trigemini and/or couplets by Holter monitoring; sustained or non-sustained ventricular tachycardia; 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 and comply with trial requirements.
- Women of childbearing potential must agree to mandatory contraceptive use during the trial and until 3 days after stopping study medication.
You will not qualify if you...
- Strict contraindications to flecainide or metoprolol use.
- Heart failure signs or symptoms, elevated N-terminal proBNP.
- Abnormal liver or kidney function (AST/ALT three times upper normal, eGFR <60).
- Prior myocardial infarction or ischemic heart disease.
- Ion channelopathy, including Brugada syndrome and long QT syndrome.
- Genetic cardiomyopathy, including hypertrophic, arrhythmogenic, dilated types, and genotype positive phenotype negative individuals.
- Atrial flutter or permanent atrial fibrillation.
- Sinus node dysfunction.
- Ongoing electrolyte disorders.
- More than moderate valvular disease.
- Pre-excitation.
- Any degree of AV-block except due to enhanced vagal tone.
- Bundle branch block or intraventricular conduction defect with QRS >120 ms.
- Prior flecainide therapy.
- Use of certain medications including CYP2D6 inhibitors/inducers, class I, III, or IV antiarrhythmic drugs, clozapine, quinidine, cimetidine, bupropion, or MAO inhibitors.
- Pregnancy.
- Unwillingness to use mandatory contraception during the trial.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Not specified
Participants start medication and dosage of Flecainide and Metoprolol or Metoprolol alone is increased to the maximum tolerable dose during this period.
1 visit (in-person) for initial dosing and ECG monitoring after first Flecainide dose
Duration - 12 months
Participants receive assigned study medication (Flecainide with Metoprolol or Metoprolol alone) to suppress ventricular arrhythmias.
Regular visits as per study protocol for medication management and monitoring
Trial Site Locations
Total: 1 location
1
Oslo University Hospital Rikshospitalet
Oslo, Norway, 0372
Actively Recruiting
Research Team
E
Eivind W Aabel, MD PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here