AuthorisedTherapeutic use (Phase IV)Interventional

An open-label, randomized clinical trial comparing Etacizin versus Propafenone in Atrial Fibrillation

This research is looking at two different medicines, Etacizin and Propafenone, for people who have atrial fibrillation. Atrial fibrillation is a common heart condition where the heart beats irregularly. The main goal of the study is to find out which medicine is better at stopping the irregular heartbeat from coming back within six months, after a patient's heart rhythm has been made normal again. Researchers will also look at how quickly the heart rhythm returns to normal with each medicine, and if the medicines affect a person's quality of life or their chances of needing to go to hospital. The study involves adults aged 18 and over, of any gender.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Olpha AS

Enrolment target

Start

11 Sep 2025

Atrial fibrillation

What is this study about?

This study is comparing two medications, Etacizin and Propafenone, to see how well they work for people who have a heart condition called atrial fibrillation. Atrial fibrillation means your heart beats irregularly, which can make you feel unwell. Often, doctors can help reset your heart to a normal rhythm.

The main aim of this study is to find out which of these two medicines is better at keeping your heart rhythm normal for at least six months after it has been reset. Researchers will be carefully checking if the irregular heartbeat comes back during this time. This is important because it can help doctors understand which treatment is most effective in the long run.

Besides looking at whether your heart rhythm stays regular, the study will also look at other things. For example, they'll check how many people get their heart rhythm back to normal with just the medicine, how long it takes for the irregular heartbeat to come back if it does, and how the medicines might affect your quality of life. The study will also count how many times people need to go to hospital because of their atrial fibrillation and look at other serious heart issues. This information helps doctors choose the best treatment for patients.

Key takeaways

Compares two medicines for irregular heartbeat (atrial fibrillation).
Aims to see which medicine best keeps heart rhythm normal for 6 months.
Open to adults aged 18 and over, both men and women.
Involves taking medication and regular health check-ups.
Your quality of life will also be assessed.

Who may be eligible?

To be part of this study, you need to be an adult, aged 18 years or older. The study is open to both men and women.

More specific details about your health condition and medical history would be shared by the study team, as these can affect whether you can join. For instance, you would need to have been diagnosed with atrial fibrillation.

Your doctor will discuss all the requirements with you to make sure the study is a safe and suitable option for your unique health situation.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of atrial fibrillation?
Are you willing to take a study medication?
Are you comfortable with regular follow-up visits with your doctor?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have your heart rhythm made normal. Then, you would be randomly assigned to receive either Etacizin or Propafenone tablets, which you would take regularly. You would be monitored closely for six months to see if your irregular heartbeat returns. This would involve a series of visits to the clinic for assessments, which might include heart rhythm checks (like EKGs) and questionnaires about your quality of life. The study would also keep track of any hospital visits related to your heart condition. The exact number of visits and tests would be explained to you by the study team, but they are all designed to safely monitor your health and the effect of the medicine.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit could be access to a treatment that might be very effective at keeping your heart rhythm stable. You would also receive close medical attention and monitoring. However, there are potential risks, as with any medication, such as side effects from the medicines. You will be fully informed of all known potential side effects. You are always in control and have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Latvia

Common questions

What is atrial fibrillation?

Atrial fibrillation is a common heart condition where the heart beats in an irregular and often fast rhythm, which can sometimes make you feel tired, dizzy, or breathless.

What does 'restored sinus rhythm' mean?

It means your heart's natural, normal beating pattern has been brought back, usually through medication or a procedure, after having an irregular rhythm.

What is the main goal of this study?

The main goal is to find out which of the two medicines, Etacizin or Propafenone, is better at keeping your heart rhythm normal for six months after it has been reset.

Will I know which medicine I'm taking?

Yes, this is an 'open-label' study, which means you and your doctors will know whether you are taking Etacizin or Propafenone.

How long will I be in the study?

The main part of the study involves monitoring your heart rhythm and health for six months after you start the treatment.