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Study of drug combination therapy in asymptomatic patients with frequent premature ventricular contractions and normal heart function to prevent left ventricular dysfunction

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 patients with premature ventricular complexes (PVCs), which are extra, abnormal heartbeats that begin in the heart's lower chambers. The study specifically looks at people who have frequent PVCs (more than 10% of total heartbeats) but don't feel any symptoms and have normal heart function. Several medications will be tested including verapamil, nebivolol, amiodarone, propafenone, bisoprolol, diltiazem, flecainide, and sotalol.

The purpose is to determine if treating patients who have frequent PVCs but no symptoms can prevent future heart problems better than simply monitoring them without treatment. The study will last for 24 months, during which patients may receive medication or, if necessary, a procedure called ablation (which uses heat to destroy small areas of heart tissue causing irregular rhythms) if medications alone don't reduce the PVCs enough.

Throughout the study, doctors will monitor how well the heart is pumping blood using special imaging tests like cardiac magnetic resonance imaging (cMRI) or heart ultrasound. They will also track changes in heart function, measure exercise capacity, and monitor for any side effects from the treatments.

The research process

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

  1. Step 1

    Initial evaluation

    Your heart function will be evaluated using cardiac magnetic resonance imaging (cMRI) or heart ultrasound if cMRI is not possible

    You will complete a quality of life questionnaire called SF-36

    Your exercise capacity will be tested on a treadmill

    A blood test will be performed to measure Nt-ProBNP (a heart function marker)

  2. Step 2

    Treatment assignment

    You will be assigned to either receive medication treatment or no treatment (regular monitoring only)

    If assigned to the medication group, treatment will begin with oral heart rhythm medications (antiarrhythmic drugs)

    The medications may include: verapamil, amiodarone, propafenone, bisoprolol, cimetidine, flecainide, or sotalol

  3. Step 3

    Follow-up visits

    You will have check-ups at 6, 12, 18, and 24 months

    During each visit, your heart rhythm will be monitored to measure PVC burden (extra heartbeats)

    At 12 months, you will complete another SF-36 quality of life questionnaire

    If you are receiving medication and your PVC burden remains above 10% after trying two different medications, additional treatment options may be discussed

  4. Step 4

    Final evaluation

    At 24 months, you will have a final heart evaluation with cMRI or heart ultrasound

    Your exercise capacity will be tested again on the treadmill

    A final blood test for Nt-ProBNP will be performed

    You will complete a final SF-36 quality of life questionnaire

Who can join the trial?

6 criteria

  • Age between 18 and 85 years old
  • Have frequent irregular heartbeats (PVCs) that occur in at least 10% of all heartbeats, regardless of whether you are currently taking heart rhythm medications
  • Have no symptoms related to the irregular heartbeats
  • Have normal heart function (left ventricular ejection fraction of 55% or higher). You can participate even if you have an underlying heart condition, as long as your heart pumping function remains normal
  • Must be able to understand and sign an informed consent form
  • Can be either male or female

Who cannot join the trial?

13 criteria

  • Age below 18 years or above 75 years
  • Presence of any symptoms related to heart rhythm disturbances (such as palpitations, dizziness, fainting)
  • Left ventricular ejection fraction (a measure of heart's pumping ability) less than normal
  • Previous treatment with antiarrhythmic drugs (medications that control heart rhythm) or ablation procedure
  • Pregnancy or planning to become pregnant during the study period
  • Having less than 10% of premature ventricular contractions (extra heartbeats originating from the lower chambers of the heart)
  • Presence of other significant heart conditions
  • Participation in other clinical trials
  • Inability to provide informed consent
  • Known allergies to medications used in the study
  • Severe kidney or liver disease that could affect medication metabolism
  • History of substance abuse that could interfere with study participation
  • Mental conditions that could affect ability to follow study requirements
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Investigated drugs

Antiarrhythmic Drugs (AADs) These are medications used to control and reduce premature ventricular complexes (PVCs), which are a type of irregular heartbeat. They help maintain normal heart rhythm and prevent heart rhythm disorders. Catheter Ablation This is not a medication but a medical procedure where small areas of heart tissue that are causing irregular heartbeats are destroyed using heat energy delivered through special catheters. In this trial, it's used as a secondary treatment option when medications don't sufficiently reduce PVCs. Note: The specific antiarrhythmic drugs are not named in the source data, but the trial mentions using up to two different lines of antiarrhythmic drug treatment before considering ablation.

What is already known about the treatment

  • Propafenone

    Propafenone is an antiarrhythmic medication taken by mouth as tablets, used to treat irregular heartbeats, especially frequent premature ventricular contractions (PVCs). This medication works by blocking the sodium channels in the heart's cells, which helps stabilize the heart rhythm and reduce extra beats that can weaken the heart muscle over time. It is classified as a class IC antiarrhythmic and is often used in patients who have many premature contractions but have not yet developed serious problems with their heart function.

  • Flecainide

    Flecainide is an antiarrhythmic medication taken by mouth as tablets, used to control abnormal heart rhythms, including frequent premature ventricular contractions. It works by blocking the abnormal electrical signals in the heart, specifically by blocking sodium channels, helping the heart maintain a regular rhythm and preventing weakening of the heart muscle. It belongs to class IC of the antiarrhythmics and is prescribed for patients with frequent extra heartbeats that can lead to complications if left untreated.

  • Sotalol

    Sotalol is an antiarrhythmic medication taken by mouth as tablets, used to treat several types of irregular heartbeats, including frequent premature ventricular contractions. This medication combines two actions: it blocks the beta receptors in the heart (like other blood pressure medications) and also blocks potassium channels, helping to normalize the heart rhythm and prevent damage to heart function. It is classified as a class III antiarrhythmic and beta-blocker, and it is an important option for patients with abnormal heart rhythms who need preventive treatment.

Investigated diseases

  • Premature Ventricular Contractions (PVCs)

    A condition where extra, abnormal heartbeats originate from the heart's lower chambers (ventricles), disrupting the normal heart rhythm. These extra beats occur earlier than the normal heartbeat sequence, causing a feeling of a skipped or fluttering heartbeat. PVCs can occur in people with otherwise normal hearts, ranging from occasional single beats to frequent episodes making up a significant percentage of total daily heartbeats. When frequent (more than 10% of total heartbeats), PVCs may lead to changes in the heart's function over time.

  • Left Ventricular Dysfunction

    A condition where the heart's main pumping chamber (left ventricle) becomes less efficient at pumping blood to the body. The condition develops gradually as the heart muscle weakens or becomes less flexible. This results in a decreased ejection fraction, which is the percentage of blood pumped out with each heartbeat. The heart may enlarge as it tries to compensate for reduced pumping efficiency.

Trial detailsLast updated 30 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-516372-14-00Protocol codeAPHP180618Estimated enrolment298 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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