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

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What is this study about?

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.

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 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 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 Quality of life assessment

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

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 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 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 Study?

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 Study?

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

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Universidade De Santiago De Compostela	Santiago De Compostela	Spain

Trial status

Country	Status	Recruitment Start
Spain	Recruiting	01.03.2024

Trial locations

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.

Investigated diseases:

Ventricular extrasystoles

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 ID:

2023-510362-26-00

Protocol code:

CARFLECT IV

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?