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Compares treatment options for Mitral Valve Prolapse
Official title Effect and Safety of Flecainide and Metoprolol Versus Metoprolol Alone to Suppress Ventricular Arrhythmias in Arrhythmic Mitral Valve Prolapse
ClinicalTrials.gov ID: NCT05631730
What this study is testing
What is Flecainide?
Flecainide is an investigational medicine, being studied as a potential treatment for mitral valve prolapse.
Also referred to as C01B C04.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
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...
- Participants must have ventricular arrhythmias, defined as at least one of the following (i) premature ventricular complex burden ≥3% per 24 hours by...
- 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...
You likely can't join if
- 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...
- 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...
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 (i) premature ventricular complex burden ≥3% per 24 hours by Holter monitoring, (ii) premature ventricular complex burden ≥1% per...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Oslo, Norway
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Oslo, Norway. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.