Comparison of Etacizine and Propafenone for maintaining normal heart rhythm in patients with atrial fibrillation

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What is this study about?

This clinical trial focuses on Atrial Fibrillation, which is an irregular and often rapid heart rhythm condition. The study compares two heart rhythm medications: Etacizin and Propafenone. Both medications are taken orally in the form of tablets and belong to a group of drugs called antiarrhythmics, which help control irregular heartbeats.

The purpose of this research is to evaluate how well Etacizin works in maintaining normal heart rhythm in patients with atrial fibrillation compared to Propafenone over a six-month period. The study is open-label, which means both patients and doctors will know which medication is being used during treatment.

During the study, participants will receive either Etacizin (up to 200 mg daily) or Propafenone (up to 900 mg daily) for approximately seven months. The research will monitor how well these medications prevent the return of irregular heart rhythm after normal heart rhythm has been restored. The study will also track other important factors such as quality of life and heart-related health events during the treatment period.

1 Initial screening and enrollment

After qualifying for the study with atrial fibrillation (irregular heart rhythm), you will undergo initial medical evaluation

Basic tests will include a standard 12-lead heart recording (ECG) or a 24-hour heart monitoring

If you are a female patient, a pregnancy test will be conducted

2 Phase I – Rhythm restoration

You will receive medication to restore normal heart rhythm

If medication alone is not effective, electrical cardioversion (procedure to restore normal heart rhythm) may be recommended

This phase continues until normal heart rhythm is achieved

3 Phase II – Maintenance treatment

Once normal heart rhythm is restored, you will be randomly assigned to receive either etacizin or propafenone

Both medications are taken orally in the form of tablets

This phase lasts for 6 months

Regular heart rhythm monitoring will be performed during this period

4 Monitoring and assessment

Your heart rhythm will be regularly checked throughout the 6-month period

Quality of life assessments will be conducted

Any hospital visits related to heart rhythm problems will be documented

Heart rate variability will be measured

Any cardiovascular events will be monitored and recorded

5 Study completion

The study will conclude after the 6-month treatment period

Final assessments will be performed to evaluate the effectiveness of the treatment

The total duration of your participation will be approximately 6 months after achieving normal heart rhythm

Who Can Join the Study?

  • Age between 18 and 70 years old at the time of signing the consent form
  • Body weight must be more than 70 kg
  • Diagnosed with paroxysmal or persistent atrial fibrillation (irregular heart rhythm) confirmed by ECG (heart electrical activity test) or 24-hour Holter monitoring
  • For women who can have children:
    • Must have a negative pregnancy test before starting
    • Must use effective birth control methods like birth control pills, injections, patches, implants, vaginal rings, or IUD
    • Or have a partner who has had a vasectomy with confirmed negative sperm counts
    • Or practice complete sexual abstinence
  • For women who cannot have children:
    • Must be post-menopausal (no menstrual periods for 12 months)
    • Or have had surgery that prevents pregnancy (such as hysterectomy)
  • Must sign an informed consent form
  • For the second phase of the study:
    • Must have normal heart rhythm either through medication or combination of medication and electrical cardioversion (procedure to restore normal heart rhythm)
    • Must be on a stable medication plan for atrial fibrillation

Who Cannot Join the Study?

  • History of severe heart failure (condition where heart cannot pump blood effectively)
  • Severe liver disease that affects liver function
  • Severe kidney disease requiring dialysis
  • History of heart attack in the past 6 months
  • Known allergic reactions to etacizin or propafenone (study medications)
  • Pregnancy or breastfeeding
  • Current participation in other clinical trials
  • Unable to provide informed consent
  • Uncontrolled high blood pressure (blood pressure that remains high despite treatment)
  • History of stroke in the past 6 months
  • Presence of other serious heart rhythm disorders
  • Thyroid disorders that are not well controlled
  • Regular use of medications that could interact with study drugs
  • History of drug or alcohol abuse in the past year
  • Life expectancy less than 6 months due to other medical conditions

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

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Other Sites

Site Name City Country Status
Pauls Stradins Clinical University Hospital Riga Latvia
Pwpdxaixd Susacrh Srjcx kauexqw Sfd Riga Latvia

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

Trial status

Country Status Recruitment Start
Latvia Latvia
Not yet recruiting
01.07.2025

Trial locations

Investigated drugs:

Etacizin is an antiarrhythmic medication used to treat irregular heartbeats. It works by stabilizing the electrical activity in the heart, helping to maintain a normal heart rhythm. This medication is particularly used in patients who have atrial fibrillation, a condition where the heart beats irregularly and often too fast.

Propafenone is also an antiarrhythmic medication that helps control abnormal heart rhythms. It works by slowing down electrical signals in the heart to help it maintain a regular beating pattern. This medication is commonly used to treat various types of irregular heartbeats, including atrial fibrillation, and helps prevent episodes of abnormal heart rhythm from occurring.

Investigated diseases:

Atrial Fibrillation – A heart rhythm disorder where the upper chambers of the heart (atria) beat irregularly and often rapidly, out of coordination with the lower chambers (ventricles). This condition occurs when the heart’s electrical system malfunctions, causing chaotic electrical signals that make the atria quiver instead of contracting effectively. The irregular heartbeat can lead to poor blood flow through the heart, potentially causing symptoms such as heart palpitations, shortness of breath, and fatigue. Atrial fibrillation can be occasional, persistent, or permanent, with episodes that may come and go or last for extended periods. The condition becomes more common with age and often affects people who have other heart conditions.

Trial ID:
2025-521267-13-01
Protocol code:
OF_ETA_CT1
Trial Phase:
Therapeutic confirmatory (Phase III)

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