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Effect and safety of flecainide and metoprolol alene to suppress ventricular arrhythmias in arrhythmic mitral valve prolapse.
EU CTIS ID: 2022-500814-24-00
What this study is testing
The main objective is to evaluate the effect and safety of adding flecainide to standard beta blocker therapy to reduce burden of ventricular arrhythmias in patients with arrhythmic mitral valve prolapse.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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: a) Premature ventricular complex burden ≥3% per 24-hours by Holter monitoring b) Premature ventricular complex burden ≥1% per 24-hours if multifocal or occurring in bi-/trigemini and/or couplets by Holter monitoring c) Sustained or non-sustained ventricular tachycardia d) Aborted cardiac arrest
- Participants must have a clinical indication for antiarrhythmic therapy 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 must accede to mandatory use of a contraceptive method for the duration of the trial and until 3 days after discontinuation of study medication.
You likely can't join if
- Strict contraindication for flecaininde or metoprolol.
- More than moderate vavular disease according to international guidelines
- Pre-excitation syndrome
- Any degree of AV-block, except due to enchanced vagal tone (e.g. Wencheback-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
See the full eligibility 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: a) Premature ventricular complex burden ≥3% per 24-hours by Holter monitoring b) Premature ventricular complex burden ≥1% per 24-hours if multifocal or occurring in bi-/trigemini and/or couplets by Holter monitoring c) Sustained or non-sustained ventricular tachycardia d) Aborted cardiac arrest
- Participants must have a clinical indication for antiarrhythmic therapy 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 must accede to mandatory use of a contraceptive method for the duration of the trial and until 3 days after discontinuation of study medication.
- Strict contraindication for flecaininde or metoprolol.
- More than moderate vavular disease according to international guidelines
- Pre-excitation syndrome
- Any degree of AV-block, except due to enchanced vagal tone (e.g. Wencheback-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: a) CYP2D6 inhibitors/inducers. b) Class I, III or IV antiarrhythmic drugs. c) Clozapine, quinidine, cimetidine bupropion. d) Monoaminoxydase (MAO) inhibitors.
- Pregnancy
- Not willing to use a mandatory contraceptive method for the duration of the trial
- Heart failure (signs or symptoms, elevated NT-proBNP) according to ICD10
- Abnormal liver or kidney function (AST/ALT three times upper normal, eGFR<60)
- Prior myocardial infarction or ischemic heart diease
- Ion channelopathy, including Brugada syndrome and long QT syndrome, according to ICD10 and ECG
- Genetic cardiomyopathy (hypertrophic cardiomyopathy, arrhythmogenic cardiomyopathy, dilated cardiomyopathy, including genotype positive phenotype negative individuals)
- Atrial flutter or permanent atrial fibrillation according to ICD10 an ECG
- Sinus node dysfunction according to ICD10 and ECG
- Ongoing electrolyte disorders
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.