Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT05631730

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

177 weeks

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

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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 confirmed by echocardiography or cardiac MRI with at least 2 mm atrial displacement of any mitral leaflet.
  • Participants must have ventricular arrhythmias defined by one or more of: premature ventricular complex burden ≥3% per 24 hours, ≥1% if multifocal or occurring in bi-/trigemini or couplets, sustained or non-sustained ventricular tachycardia, or aborted cardiac arrest.
  • Participants must have a clinical indication for antiarrhythmic treatment due to ventricular arrhythmias.
  • Participants must be capable of providing signed informed consent and comply with study requirements.
  • Women of childbearing potential must agree to use a contraceptive method during the trial and for 3 days after stopping study medication.
Not Eligible

You will not qualify if you...

  • Contraindications to flecainide or metoprolol use.
  • Heart failure, including signs, symptoms, or elevated N-terminal proBNP.
  • Abnormal liver or kidney function (AST/ALT elevated three times above normal, or eGFR <60).
  • Prior myocardial infarction or ischemic heart disease.
  • Ion channelopathies including Brugada syndrome and long QT syndrome.
  • Genetic cardiomyopathies including hypertrophic, arrhythmogenic, or dilated types.
  • Atrial flutter or permanent atrial fibrillation.
  • Sinus node dysfunction.
  • Ongoing electrolyte disorders.
  • More than moderate valvular disease by guidelines.
  • Pre-excitation.
  • Any degree of AV-block except vagal tone related.
  • Bundle branch block or intraventricular conduction defect with QRS >120 ms.
  • Prior flecainide therapy.
  • Use of CYP2D6 inhibitors/inducers, class I, III, or IV antiarrhythmic drugs, clozapine, quinidine, cimetidine, bupropion, or MAO inhibitors.
  • Pregnancy or unwillingness to use mandatory contraceptive methods during the trial.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Oslo University Hospital Rikshospitalet

Oslo, Norway, 0372

Actively Recruiting

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Research Team

E

Eivind W Aabel, MD PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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