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Comparison of Carvedilol and Flecainide Treatment in Patients with Idiopathic Ventricular Arrhythmias

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What is this trial about?

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

This clinical trial focuses on idiopathic ventricular arrhythmias, a heart condition where the heart beats irregularly without a known cause. The study compares two medications: carvedilol and flecainide, which are taken as oral tablets to treat irregular heart rhythms. The purpose is to determine which medication is more effective in reducing irregular heartbeats.

Participants will receive either carvedilol (up to 50 mg daily) or flecainide (up to 300 mg daily) for a period of 12 months. During the study, heart activity will be monitored using a Holter-ECG, which is a portable device that records heart rhythms over 24 hours. The recordings will be taken before starting treatment and after completing it.

The study will also look at how these medications affect overall quality of life and heart function. Heart function will be evaluated using echocardiography, a test that uses sound waves to create pictures of the heart. The study will track any side effects that participants may experience during the treatment period.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial heart monitoring

    A 24-hour heart monitoring (Holter-ECG) will be performed before starting any treatment to measure your current heart rhythm irregularities

  2. Step 2

    Treatment phase - first medication

    You will receive either carvedilol or flecainide medication to take orally

    The medication will be gradually adjusted to reach the target dose

    You will need to take the medication as prescribed throughout the treatment period

  3. Step 3

    Follow-up heart monitoring

    After completing the first medication period, another 24-hour heart monitoring will be conducted to measure changes in heart rhythm

  4. Step 4

    Quality of life assessment

    You will complete a quality of life questionnaire (SF36) to evaluate how the treatment affects your daily life

  5. Step 5

    Heart function testing

    A heart ultrasound test will be performed to check your heart function

    This test will measure your left ventricle function and heart muscle movement

  6. Step 6

    Safety monitoring

    Throughout the study, your health will be monitored for any side effects

    Regular check-ups will be scheduled to ensure your safety during the treatment

  7. Step 7

    Study completion

    The study is expected to continue until June 2025

    Final evaluations will be conducted to assess the overall effectiveness of the treatment

Who can join the trial?

6 criteria

  • Must be at least 18 years old and able to provide informed consent
  • Must have idiopathic ventricular arrhythmias (irregular heart rhythms that originate in the lower chambers of the heart without a known cause)
  • Can be either male or female
  • Must be able to undergo 24-hour Holter-ECG monitoring (a portable device that continuously records your heart's rhythm)
  • Must not belong to any vulnerable population groups (such as prisoners, mentally disabled persons, or other protected groups)
  • Must be willing to complete all required heart monitoring before and after the treatment

Who cannot join the trial?

14 criteria

  • Age under 18 years or over 65 years
  • Pregnancy or breastfeeding
  • History of structural heart disease (problems with heart muscle or valves)
  • Previous heart attack or heart surgery
  • Presence of other types of heart rhythm disorders
  • Current treatment with other antiarrhythmic medications (drugs that control heart rhythm)
  • Severe kidney or liver problems
  • Uncontrolled thyroid disorders (conditions affecting the thyroid gland)
  • Known allergies to the study medications
  • Participation in other clinical trials within the past 30 days
  • Inability to comply with study procedures, including 24-hour Holter monitoring (continuous heart rhythm recording)
  • Presence of any condition that could interfere with the study results
  • History of drug or alcohol abuse within the past year
  • Mental conditions that could affect ability to provide informed consent
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Investigated drugs

  • Carvedilol

    is a medication known as a beta-blocker. It works by blocking certain natural chemicals in your body (such as epinephrine) that affect the heart and blood vessels. This helps reduce heart rate, blood pressure, and strain on the heart. In this trial, it's being studied for treating irregular heart rhythms originating from the ventricles (lower chambers of the heart).

  • Flecainide

    is an antiarrhythmic medication that works by stabilizing the electrical activity in the heart. It helps control irregular heartbeats by slowing down electrical signals in the heart tissue. This medication is commonly used to treat various types of abnormal heart rhythms, particularly those originating in the ventricles.

What is already known about the treatment

  • Carvedilol

    A beta-blocker medication administered orally in tablet form that works by blocking certain natural chemicals in your body (such as epinephrine) that affect the heart and blood vessels. It's widely used in modern cardiology for treating various heart conditions, particularly ventricular arrhythmias, high blood pressure, and heart failure. The medication acts by reducing the workload on the heart and helping it beat more regularly, while also blocking both beta and alpha receptors in the heart and blood vessels, making it a unique dual-action beta-blocker.

  • Flecainide

    An antiarrhythmic medication taken orally as tablets that works by stabilizing the electrical signals in the heart to maintain a regular heartbeat. It's commonly prescribed for treating various types of irregular heart rhythms, particularly ventricular arrhythmias, and belongs to the Class IC antiarrhythmic drug category. The medication functions by slowing electrical signals in the heart to help restore normal heart rhythm, specifically by blocking sodium channels in heart muscle cells, which helps prevent abnormal electrical activity that can lead to arrhythmias.

Investigated diseases

Idiopathic Ventricular Arrhythmia - A heart rhythm disorder that originates in the ventricles (lower chambers of the heart) without any identifiable underlying cause. It is characterized by irregular heartbeats that occur when the heart's electrical signals originate abnormally from the ventricles rather than the normal pacemaker of the heart. The condition can manifest as premature ventricular contractions (extra heartbeats) or more complex rhythm disturbances. The arrhythmia typically presents with symptoms such as palpitations, irregular heartbeat sensations, or heart fluttering. The condition may occur in people with otherwise structurally normal hearts.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510362-26-00Protocol codeCARFLECT IVEstimated enrolment32 patientsSponsorFundacion Publica Galega Instituto De Investigacion Sanitaria De Santiago De Compostela

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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