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

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What is this study about?

This clinical trial is focused on studying the effects and safety of a treatment for people with arrhythmic mitral valve prolapse. This condition involves a problem with the heart’s mitral valve, which can lead to irregular heartbeats known as ventricular arrhythmias. The study will compare the use of two medications: flecainide and metoprolol, against the use of metoprolol alone. Flecainide and metoprolol are both medications used to help control abnormal heart rhythms.

The purpose of the study is to see if adding flecainide to the standard treatment with metoprolol can better reduce the number of irregular heartbeats in patients with arrhythmic mitral valve prolapse. Participants in the study will receive either the combination of flecainide and metoprolol or metoprolol alone. The study will last for a period of 13 weeks, during which the effects of the medications on heart rhythm will be closely monitored.

Throughout the study, participants will be asked to take their medication as prescribed and attend regular check-ups to monitor their heart health. The study aims to provide valuable information on whether the combination of these medications can offer better control of heart rhythm issues in people with arrhythmic mitral valve prolapse, potentially improving their quality of life.

1 joining the trial

Upon joining the trial, participants must be 18 years or older and have a condition called arrhythmic mitral valve prolapse. This condition is confirmed through specific heart imaging tests.

Participants must have certain types of irregular heartbeats, known as ventricular arrhythmias, and a need for treatment to manage these irregularities.

2 consent and compliance

Participants must provide signed informed consent, agreeing to follow the trial’s requirements and restrictions.

Participants must agree to use a contraceptive method during the trial and for three days after stopping the study medication.

3 medication phase 1

Participants will begin taking metoprolol, a medication taken orally. The dosage and frequency will be determined by the study team based on individual needs.

This phase aims to establish a baseline for how the body responds to metoprolol alone.

4 medication phase 2

Participants will then start taking a combination of flecainide and metoprolol, both taken orally. The dosage and frequency will be determined by the study team.

This phase evaluates the effect and safety of adding flecainide to the standard metoprolol therapy.

5 monitoring and assessments

Throughout the trial, participants will undergo regular monitoring, including 24-hour heart rhythm recordings, to assess the number and severity of irregular heartbeats.

Participants’ health-related quality of life will also be evaluated using a specific questionnaire.

6 end of trial

The trial is expected to conclude by October 31, 2025. Participants will have a final assessment to evaluate the overall impact of the treatment on their heart condition.

Who Can Join the Study?

Participants must be 18 years of age or older at the time of signing the informed consent.
Participants must have mitral valve prolapse, which is a condition where the valve between the heart’s left upper chamber and left lower chamber doesn’t close properly. This must be evident by tests like echocardiography or cardiac magnetic resonance imaging, showing a displacement of the mitral leaflets by 2 mm or more.
Participants must have ventricular arrhythmias, which are irregular heartbeats starting in the heart’s lower chambers. This can be shown by:
- Premature ventricular complex burden of 3% or more per 24 hours, measured by Holter monitoring.
- Premature ventricular complex burden of 1% or more per 24 hours if they are multifocal (coming from different places in the heart) or occurring in patterns like bi-/trigemini or couplets, measured by Holter monitoring.
- Sustained or non-sustained ventricular tachycardia, which are fast heart rhythms.
- Aborted cardiac arrest, which is a situation where the heart stops but is restarted.
Participants must have a clinical indication for antiarrhythmic therapy due to ventricular arrhythmias, meaning they need treatment to manage these irregular heartbeats.
Participants must be capable of giving signed informed consent, which means they understand the study and agree to follow its requirements and restrictions.
Participants must agree to the mandatory use of a contraceptive method for the duration of the trial and until 3 days after stopping the study medication.

Who Cannot Join the Study?

Patients with a history of arrhythmic mitral valve prolapse cannot participate. This is a condition where the heart’s mitral valve doesn’t close properly, causing irregular heartbeats.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not willing to follow the study procedures and requirements cannot participate.
Patients with other serious health conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who are currently participating in another clinical trial cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Oslo Universitetssykehus HF	Oslo	Norway

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Norway	Recruiting	01.09.2022

Trial locations

Investigated drugs:

Flecainide is a medication used to help control irregular heartbeats. In this trial, it is being tested to see if it can help reduce the number of abnormal heart rhythms in people with a condition called arrhythmic mitral valve prolapse. The researchers want to find out if adding flecainide to the usual treatment can make a difference in managing these heart rhythm problems.

Metoprolol is a medication that belongs to a group of drugs known as beta blockers. It is commonly used to treat high blood pressure and heart-related issues. In this study, metoprolol is used as the standard treatment to help manage heart rhythm problems. The trial is looking at how well metoprolol works on its own and in combination with another medication, flecainide, to control irregular heartbeats in patients with arrhythmic mitral valve prolapse.

Investigated diseases:

Mitral valve prolapse

Arrhythmic mitral valve prolapse – This condition involves the mitral valve in the heart, which does not close properly, leading to blood leaking backward into the left atrium. Over time, this can cause irregular heartbeats, known as arrhythmias, due to the abnormal movement of the valve. The prolapse can lead to increased stress on the heart, potentially causing the heart muscle to thicken or enlarge. As the condition progresses, patients may experience palpitations, dizziness, or shortness of breath. The severity of symptoms can vary, with some individuals experiencing mild discomfort and others facing more significant challenges. The condition is often monitored to assess changes in heart function and the development of arrhythmias.

Trial ID:

2022-500814-24-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?