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 (FLECAPRO).

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-500814-24-00

Enrollment

Registered

2022-09-27

Start date

2023-01-04

Completion date

Unknown

Last updated

2025-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmic mitral valve prolapse

Brief summary

Number of ventricular tachyarrhythmias, composite of: a) Ventricular tachycardia b) Ventricular fibrillation.

Detailed description

Burden of premature ventricular complexes (by 24-hour Holter monitoring), Health-related quality of life (number of patients with ≥5 points increase in SF-36 overall summary score), Number of severe ventricular tachycardias, composite of: a) Non-sustained ventricular tachycardia with syncope b) Sustained ventricular tachycardia c) Ventricular fibrillation

Interventions

DRUGMETOPROLOL

DRUGFLECAINIDE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Number of ventricular tachyarrhythmias, composite of: a) Ventricular tachycardia b) Ventricular fibrillation.	—

Secondary

Measure	Time frame
Burden of premature ventricular complexes (by 24-hour Holter monitoring), Health-related quality of life (number of patients with ≥5 points increase in SF-36 overall summary score), Number of severe ventricular tachycardias, composite of: a) Non-sustained ventricular tachycardia with syncope b) Sustained ventricular tachycardia c) Ventricular fibrillation	—

Countries

Norway

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026