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

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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 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.

The research process

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

Step 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
Step 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
Step 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
Step 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
Step 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 trial?

12 criteria

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
check
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
- check
  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 trial?

15 criteria

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

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Pauls Stradins Clinical University Hospital
Riga, Latvia

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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.

Propafenone Hydrochloride

What is already known about the treatment

Etacizin
An antiarrhythmic medication administered orally in tablet form, primarily used for treating atrial fibrillation and maintaining normal heart rhythm. This Class IC antiarrhythmic drug works by blocking sodium channels in heart cells, which helps control irregular heartbeat patterns. Etacizin is particularly valued in clinical practice for its ability to maintain sinus rhythm in patients with atrial fibrillation, with a relatively favorable safety profile compared to some other antiarrhythmic medications.
Propafenone
A widely-used antiarrhythmic medication taken orally, belonging to Class IC antiarrhythmic agents, specifically designed to treat and prevent various types of irregular heartbeats, including atrial fibrillation. It functions by slowing electrical signals in the heart through sodium channel blockade, helping to restore and maintain normal heart rhythm. Propafenone has been well-established in medical practice for many years and is considered a standard treatment option for managing atrial fibrillation, particularly in patients without structural heart disease.

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.