Using Flecainide with Metoprolol to Treat Ventricular Arrhythmias in Mitral Valve Prolapse
An Investigator-Initiated Prospective Randomized Open-Label Blinded-Endpoint Crossover Trial Comparing the Effect and Safety of Flecainide and Metoprolol Versus Metoprolol Alone to Suppress Ventricular Arrhythmias in Arrhythmic Mitral Valve Prolapse
This study is testing if adding flecainide to the usual treatment with metoprolol can help people with mitral valve prolapse and heart rhythm problems feel better and stay safer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 1 site (Oslo) |
| Trial ID | NCT05631730 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness and safety of adding flecainide to standard treatment with metoprolol for patients suffering from ventricular arrhythmias associated with arrhythmic mitral valve prolapse. It is a randomized controlled crossover trial that will utilize an implantable loop recorder to monitor arrhythmia burden and assess outcomes. The study aims to address the lack of established medical therapies for this condition, which can lead to severe complications, including sudden cardiac death. Participants will be closely monitored to determine the impact of the combined treatment on their arrhythmias.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with diagnosed mitral valve prolapse and documented ventricular arrhythmias requiring treatment.
Not a fit: Patients without mitral valve prolapse or those whose arrhythmias are caused by other underlying conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the frequency of dangerous ventricular arrhythmias in patients with mitral valve prolapse.
How similar studies have performed: While there is limited research specifically on this combination therapy, similar approaches have shown promise in managing ventricular arrhythmias in other contexts.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Oslo
- Oslo University Hospital Rikshospitalet — Oslo, Norway (Recruiting)
Study contacts
- Principal investigator: Eivind W Aabel, MD PhD — Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway
- Study coordinator: Eivind W Aabel, MD PhD
- Email: eivind.westrum.aabel@gmail.com
- Phone: 41243148
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.