RecruitingRare disease

Study of flecainide alone or with beta-blockers or calcium channel blockers and quinidine for treating ventricular arrhythmias in patients with Andersen-Tawil syndrome and MEPPC

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on two rare heart conditions: Andersen-Tawil syndrome and Multifocal Ectopic Purkinje-related Premature Contractions. These conditions cause irregular heartbeats that originate from specific areas of the heart. The study aims to find the most effective treatment for controlling abnormal heart rhythms in patients with these conditions.

The study will test several medications including flecainide, which will be used alone or in combination with other heart medications. These additional medications include beta-blockers (bisoprolol, metoprolol, nebivolol, propranolol, atenolol) and calcium channel blockers like verapamil. For patients with Multifocal Ectopic Purkinje-related Premature Contractions, the medication quinidine will also be tested.

During the study, participants will take different combinations of these medications for specific periods. The medications will be given as oral tablets, and the treatment will continue for several weeks to determine which combination works best for each individual patient in controlling their irregular heart rhythms.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial medication period
You will continue taking your current stable dose of flecainide medication for at least 3 months
During this period, your heart rhythm will be monitored using a Holter monitor or other rhythm monitoring device to measure ventricular arrhythmia
Step 2
Treatment phase one
You will receive either flecainide alone or flecainide combined with additional medications
The additional medications may include beta-blockers (such as bisoprolol, metoprolol, nebivolol, propranolol, or atenolol) or calcium channel blockers
Your heart rhythm will continue to be monitored to measure the number of irregular heartbeats over 24 hours
Step 3
Treatment phase two (for MEPPC patients only)
If you have been diagnosed with Multifocal Ectopic Purkinje-related Premature Contractions (MEPPC), you will receive either flecainide or quinidine
Your heart rhythm will be monitored to compare the effectiveness of these medications
Step 4
Monitoring throughout study
Regular heart rhythm monitoring will continue throughout the study period
The study will measure how many irregular heartbeats occur in each 24-hour period
The total duration of the study will be from April 2024 to May 2025

Who can join the trial?

6 criteria

You must be diagnosed with either Andersen-Tawil syndrome (ATS) or Multifocal Ectopic Purkinje-related Premature Contractions (MEPPC)
You must have shown signs of irregular heart rhythms (ventricular arrhythmias) during previous heart monitoring with a Holter monitor (a portable device that records your heart's activity), loop recorder, or ECG patch
You must be currently taking flecainide (a medication used to treat heart rhythm problems) at a stable dose for at least 3 months
You must be at least 18 years old
For MEPPC patients: You must have a confirmed genetic test showing a specific variation in the SCN5A gene (classified as class 4 or 5)
Both men and women can participate in this study

Who cannot join the trial?

15 criteria

Age under 18 years or over 65 years
Pregnancy or breastfeeding
Known allergies or hypersensitivity to flecainide, quinidine, beta-blockers, or calcium channel blockers (medications used in the study)
Severe kidney or liver problems that could affect drug metabolism
History of severe heart failure or significant heart structural abnormalities
Current participation in other clinical trials
Inability to provide informed consent
Severe psychiatric conditions that could interfere with study compliance
History of substance abuse in the past 6 months
Use of medications that could interact with study drugs
Uncontrolled high blood pressure
History of significant bleeding disorders
Major surgery planned during the study period
Life expectancy less than the duration of the study
Any condition that, in the investigator's opinion, makes the patient unsuitable for the study

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Verified sites

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Amsterdam UMC
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Amsterdam, The Netherlands

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Investigated drugs

Flecainide
is a medication that helps control irregular heart rhythms (arrhythmias). It works by slowing down electrical signals in the heart to maintain a normal heart rhythm.
Beta-blockers
are medications that reduce the workload on the heart and help control heart rate. They work by blocking the effects of certain stress hormones on the heart.
Calcium channel blockers
are medications that help relax blood vessels and reduce the heart's workload. They also help control irregular heart rhythms by affecting how calcium moves in heart cells.
Quinidine
is a medication used to treat irregular heart rhythms. It works by stabilizing electrical activity in the heart to help maintain a regular heart rhythm pattern.

What is already known about the treatment

Flecainide
A cardiac antiarrhythmic medication taken orally in tablet form that works by slowing electrical signals in the heart to stabilize heart rhythm. It is actively used in modern medicine to treat various types of irregular heartbeats, particularly in conditions like Andersen-Tawil syndrome and premature ventricular contractions. The medication works by blocking sodium channels in heart cells, which helps control the electrical activity that causes abnormal heart rhythms. It belongs to the Class IC antiarrhythmic drug classification.
Quinidine
An antiarrhythmic medication administered orally that helps maintain normal heart rhythm by regulating electrical activity in the heart. It is well-established in medical literature and continues to be used for treating specific types of irregular heartbeats, including multifocal ectopic Purkinje-related premature contractions. The drug works by blocking sodium and potassium channels in heart cells, helping to normalize the heart's electrical conduction system, and belongs to the Class IA antiarrhythmic medication group.
Beta-blockers
A class of medications typically taken orally that work by blocking the effects of adrenaline and similar hormones on the heart. These drugs are widely used in current medical practice to treat various heart conditions, including arrhythmias and high blood pressure. They function by reducing the heart rate and the force of heart contractions, making the heart work more efficiently while decreasing its workload.
Calcium channel blockers
A group of medications taken orally that work by preventing calcium from entering the cells of the heart and blood vessels. These medications are commonly used in modern medicine to treat various cardiovascular conditions, including certain types of arrhythmias and high blood pressure. They function by relaxing blood vessels and reducing the workload on the heart, while also helping to control abnormal heart rhythms.

Investigated diseases

Andersen-Tawil Syndrome
A rare genetic disorder that affects the heart's rhythm and can cause periodic muscle weakness. The condition disrupts the normal movement of ions in heart cells and muscle cells, leading to irregular heartbeats. People with this syndrome may experience episodes of temporary muscle weakness that can affect different parts of the body. The condition is present from birth, though symptoms may not appear until childhood or early adulthood.
Multifocal Ectopic Purkinje-related Premature Contractions
A rare heart rhythm condition where multiple areas in the heart's electrical system produce extra heartbeats. These extra beats originate from the Purkinje fibers, which are specialized heart cells that help coordinate heartbeats. The condition causes frequent premature heartbeats that can occur throughout the day. It is typically present from an early age and can persist throughout life.