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

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What is this study about?

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.

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

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

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

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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Azpndrioq Udn Amsterdam The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Recruiting
01.04.2024

Trial locations

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.

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.

Trial ID:
2024-510682-42-01
NCT ID:
NCT06205550
Trial Phase:
Therapeutic confirmatory (Phase III)

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