Mitral valve prolapse Trials in Disease

Study on the Effect and Safety of Flecainide and Metoprolol for Patients with Arrhythmic Mitral Valve Prolapse

This clinical trial is focused on studying the effects and safety of a treatment for people with arrhythmic mitral valve prolapse, a condition where the heart's mitral valve doesn't close properly, leading to irregular heartbeats known as ventricular arrhythmias. The study compares the use of two medications together—flecainide and metoprolol—against the use of metoprolol alone.

Main inclusion criteria: Participants must be 18 years or older and have confirmed mitral valve prolapse shown through heart imaging tests such as echocardiography or cardiac magnetic resonance imaging, with a displacement of the mitral leaflets by 2 mm or more. They must also have ventricular arrhythmias, which are irregular heartbeats originating in the heart's lower chambers. This can be demonstrated by a premature ventricular complex burden of 3% or more per 24 hours on Holter monitoring, or 1% or more if the beats are multifocal or occur in specific patterns. Participants must have a clinical need for antiarrhythmic therapy, be able to provide informed consent, and agree to use contraception during the trial and for three days after stopping the medication.

Main exclusion criteria: Patients cannot participate if they have a history of arrhythmic mitral valve prolapse that makes them unsuitable for the study, if they fall outside the specified age range, if they are unwilling to follow study procedures, if they have other serious health conditions that might interfere with the trial, if they are pregnant or breastfeeding, or if they are currently participating in another clinical trial.

Trial focus and goal: The purpose of this study is to determine whether adding flecainide to the standard treatment with metoprolol can better reduce the number of irregular heartbeats in patients with arrhythmic mitral valve prolapse. The trial will last for 13 weeks, during which participants will receive either the combination of flecainide and metoprolol or metoprolol alone. Throughout the study, heart rhythm will be closely monitored using 24-hour heart rhythm recordings, and participants' health-related quality of life will be evaluated. The study aims to provide valuable information on whether this medication combination can offer better control of heart rhythm issues, potentially improving patients' quality of life.

Investigational drugs: The trial is testing flecainide, a medication used to help control irregular heartbeats by blocking certain electrical signals in the heart that cause these irregular rhythms. Flecainide belongs to a class of medications known as antiarrhythmics, which work by stabilizing the heart's electrical activity. The second medication is metoprolol, a beta-blocker commonly used to treat high blood pressure and heart-related issues. Metoprolol works by slowing down the heart rate and reducing the heart's workload, helping to maintain a steady and regular heartbeat. Both medications are taken orally in tablet form.