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Flecainide versus Bisoprolol as First-Line Treatment for Premature Ventricular Contractions in Adult Patients: A Multicenter Randomized Trial

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

The study focuses on people who experience Premature Ventricular Contractions, which are extra heartbeats that start in the lower chambers of the heart and can cause a feeling of skipped beats or fluttering. Two oral medicines are being compared as first‑line treatment: flecainide, which works by slowing the electrical signals that cause these extra beats, and bisoprolol, a beta‑blocker that reduces heart rate and the force of contraction. The purpose of the study is to determine which medication more effectively reduces the number of extra beats.

Participants will take the assigned medication for about three months. Their heart rhythm will be recorded using a portable device called a Holter-ECG, which continuously monitors the heart’s electrical activity for a week at the start of the study and again after three months. In addition, participants will answer simple questionnaires that measure overall well‑being, including the EQ-5D visual scale and the SF-12 health survey, to see how the treatment impacts daily life.

Throughout the study, any side effects such as fatigue, dizziness, low blood pressure, or more serious heart problems will be recorded. The need for additional procedures, such as a catheter-based technique to destroy the source of the extra beats, will also be noted. The overall goal is to find the safer and more effective option for managing these premature heartbeats.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit and randomization

    You attend the first study visit after joining the trial. during this visit a 7‑day heart rhythm recording (Holter‑ECG) is performed to measure the number of premature ventricular contractions (PVC) you have. you also complete questionnaires about your quality of life. after these assessments you are randomly assigned to receive either flecainide or bisoprolol as the study medication.

  2. Step 2

    Start of study medication

    If you are assigned to the flecainide group, you take one oral tablet of flecainide 150 mg each day. if you are assigned to the bisoprolol group, you take one oral tablet of bisoprolol 2.5 mg each day. the medication is taken at the same time each day, with water, and you continue taking it for the entire three‑month treatment period.

  3. Step 3

    Daily monitoring and symptom tracking

    Throughout the three‑month period you keep a simple diary of any symptoms such as fatigue, dizziness, blurred vision, tremor, or feeling faint. you also note any episodes of fast heart rhythm or low heart rate. this information helps the study team evaluate safety.

  4. Step 4

    Three‑month follow‑up visit

    After three months you return for a follow‑up visit. another 7‑day Holter‑ECG recording is done to compare the number of PVCs with the baseline measurement. you again complete the quality‑of‑life questionnaires (EQ‑5D visual analogue scale and SF‑12). the study staff reviews your symptom diary and checks for any adverse events, such as serious heart problems, hospitalizations, or minor issues like low blood pressure or heart‑rate slowing. if needed, the doctor discusses whether a catheter ablation procedure might be required.

  5. Step 5

    Completion of study participation

    After the three‑month assessments are finished, the study medication is stopped. all data collected during the trial are recorded for analysis. no further study‑specific visits are required unless your regular doctor advises otherwise.

Who can join the trial?

7 criteria

  • Age 18 years or older.
  • At least one symptom such as palpitations (feeling of a fast or irregular heartbeat), presyncope (feeling about to faint), dyspnea (shortness of breath), or fatigue that occurred within the past month.
  • No need for, or refusal of, first‑line catheter ablation (a procedure that uses heat or cold to destroy the small area of the heart that causes extra beats) because the extra beats are not easily treated that way or come from many places.
  • Left ventricular ejection fraction (LVEF) 45% or higher measured by transthoracic echocardiography (an ultrasound of the heart) or cardiac magnetic resonance imaging (a detailed heart scan). LVEF is the percentage of blood the main pumping chamber pushes out with each beat.
  • No evidence of ischemic heart disease (no reduced blood flow to the heart or significant artery blockage) as shown by stress tests, imaging, or angiography performed within the past year.
  • Must be enrolled in Social Security.
  • Must sign a written consent form.

Who cannot join the trial?

15 criteria

  • Family heart‑channel disorders such as long QT syndrome, Brugada syndrome, or catecholaminergic polymorphic ventricular tachycardia – inherited conditions that affect the heart’s electrical system.
  • Sustained atrial arrhythmia meaning a continuous abnormal rhythm in the upper chambers of the heart, including atrial fibrillation, atrial tachycardia, or atrial flutter.
  • Congestive heart failure – signs or symptoms of the heart not pumping well, or an elevated blood test called NT‑proBNP that indicates heart stress.
  • Any abnormal finding on the heart’s electrical test (ECG) at the start of the study, such as a QRS width greater than 120 ms (wide heart signal), pre‑excitation (extra pathways that speed up electrical flow), or any type of AV‑block (delay or blockage of signals between the upper and lower heart chambers) that is not due to normal increased vagal tone.
  • Abnormal liver or kidney function – liver enzymes (AST/ALT) three times higher than normal or a kidney filtration rate (eGFR) less than 50 ml/min/1.73 m².
  • Asthma that requires medication to open the airways (bronchodilation therapy).
  • Currently taking part in another clinical trial of a drug or device, or having finished another trial less than 30 days ago.
  • Previous low potassium level (hypokalemia) with potassium less than 3 mmol/L.
  • Known pregnancy, breastfeeding, or any condition that could lead to pregnancy in a woman who could become pregnant.
  • Allergy or known severe reaction to flecainide, bisoprolol, or any of their inactive ingredients, or any medical reason that makes taking these medicines unsafe (contraindications).
  • Planned use of medicines that are not allowed in this study.
  • Being under legal guardianship, judicial protection, or curatorship.
  • Genetic cardiomyopathy – inherited heart muscle disease such as hypertrophic (thickened heart muscle), arrhythmogenic (muscle that causes abnormal rhythms), or dilated (enlarged heart chambers) cardiomyopathy, even if the person has the gene but no symptoms yet.
  • Active heart muscle inflammation (myocarditis) or a previous episode of myocarditis that left lasting damage.
  • Sustained ventricular tachycardia – a fast, abnormal rhythm in the lower chambers of the heart lasting 30 seconds or more.
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Investigated drugs

  • FLECAINIDE

    is an oral medication that works by slowing the electrical signals in the heart. In this trial it is being tested as the first treatment option for people who have premature heartbeats that start in the lower chambers of the heart (ventricular premature contractions). The study will see how well it reduces the number of these early beats and improves symptoms compared with another drug.

  • BISOPROLOL

    is an oral medication that belongs to a group of drugs called beta‑blockers. It is used in the trial as a comparison treatment for the same type of early heartbeats. The purpose is to see whether the new medication (flecainide) works better, the same, or worse than this standard therapy in controlling the premature heartbeats.

What is already known about the treatment

  • FLECAINIDE

    Flecainide is taken by mouth as a tablet and is an approved prescription drug that has been studied for decades in the treatment of irregular heartbeats. It is mainly used to control premature ventricular contractions and other fast heart rhythms. It works by blocking sodium channels in heart cells, which slows the electrical signals that cause the heart to beat too quickly. It belongs to the class Ic anti‑arrhythmic group of medicines.

  • BISOPROLOL

    Bisoprolol is taken by mouth as a tablet and is a widely prescribed beta‑blocker that has a long history of use in cardiovascular care. It is mainly used to lower heart rate and blood pressure and can help reduce premature ventricular contractions. It works by selectively blocking beta‑1 receptors in the heart, which reduces the effects of adrenaline and slows the heart down. It is classified as a cardio‑selective beta‑adrenergic blocker.

Investigated diseases

Premature ventricular contractions - Premature ventricular contractions are early heartbeats that start in the ventricles. They happen when an electrical impulse arises before the normal beat, causing an extra contraction. The extra beats may appear as isolated events or in repeating patterns. Over time, the number of these premature beats can increase, leading to more frequent irregular heart rhythms. Their frequency may vary with activity, stress, or rest.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524584-20-00Protocol codeAPHP250850Estimated enrolment158 patientsSponsorAssistance Publique Hopitaux De Paris

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