A Study to Test How Well PKN605 Works and How Safe It Is in Patients with Atrial Fibrillation

What is this study about?

This study is looking at a heart condition called atrial fibrillation, which is an irregular heartbeat that can cause various symptoms and increase the risk of stroke. The study will test a medication called PKN605, which comes in film-coated tablets that are taken by mouth. Some participants will receive PKN605 while others will receive a placebo. The purpose of this study is to see how well PKN605 works in reducing the amount of time people spend in atrial fibrillation, which is called atrial fibrillation burden.

During the study, participants will wear heart monitoring patches that record their heart rhythm to measure how much time they spend in atrial fibrillation. The study will also look at how safe the medication is by checking for any unwanted effects, measuring vital signs like blood pressure and heart rate, and doing blood tests. The researchers will also measure the amount of medication in the blood at different times to understand how the body processes it. Participants need to be in normal heart rhythm at the start of the study, which means those with persistent atrial fibrillation will need to have their heart rhythm corrected before joining.

The study will track when participants experience episodes of atrial fibrillation using various monitoring methods including the heart patches, standard heart tracings, and handheld devices. Participants will already need to be taking medication to prevent stroke, as recommended by medical guidelines for people with atrial fibrillation. The study will continue for several months to gather enough information about how well the medication works and whether it is safe for people with this heart condition.

1 Initial assessment and treatment preparation

After joining the study, your heart rhythm will be checked using a 12-lead ECG, which is a test that records the electrical activity of your heart using electrodes placed on your skin.

If you are experiencing persistent atrial fibrillation (an irregular heart rhythm that continues without stopping on its own), a procedure called cardioversion will be performed at least 12 hours before you receive your first dose. This procedure helps restore your normal heart rhythm.

Your heart must be in sinus rhythm (normal, regular heartbeat) before you can start receiving the study medication.

2 Randomization and start of treatment

You will be randomly assigned to receive either PKN605 or placebo. A placebo looks like the actual medication but contains no active ingredient.

Neither you nor your doctor will know which treatment you are receiving during the study.

The study medication is a film-coated tablet that you will take by mouth.

The dosage form available is PKN605 50 mg tablets.

3 Regular monitoring visits

Throughout the study, you will attend regular clinic visits for monitoring.

At these visits, blood samples will be collected to measure the levels of PKN605 in your blood. Samples will be taken before you take your dose, 2 hours after taking your dose, and 4 hours after taking your dose.

Your vital signs (such as blood pressure, heart rate, and temperature) will be measured.

A 12-lead ECG will be performed to check your heart rhythm and electrical activity.

Laboratory tests will be conducted using your blood samples to monitor your overall health and check for any side effects.

4 Continuous heart rhythm monitoring

You will be asked to wear an ECG patch monitor at specific times during the study. This is a small device that sticks to your skin and continuously records your heart rhythm.

The monitor will measure your atrial fibrillation burden, which is the amount of time your heart spends in an irregular rhythm compared to the total monitoring time.

The monitor will also detect if and when your atrial fibrillation returns after starting treatment.

Additional methods such as handheld ECG devices or other approved monitoring methods may also be used to check your heart rhythm.

5 Safety monitoring

Throughout the study, any adverse events (unwanted or unexpected symptoms or health problems) will be recorded and monitored.

Specific attention will be paid to your heart rhythm measurements, including QTcF (a measurement of the time it takes for your heart to reset between beats, adjusted for heart rate).

All safety information will be collected during your regular visits to ensure your well-being during the study.

6 Continuation of standard care

You will continue to receive your standard stroke prevention treatment as recommended by medical guidelines throughout the entire study.

This treatment is separate from the study medication and will be maintained as prescribed by your doctor.

Who Can Join the Study?

You must sign a consent form before joining the study
You must be older than 18 years of age
You must be male or female
You must have had at least 2 episodes of atrial fibrillation, which is an irregular heartbeat
At least one episode of atrial fibrillation must have occurred within the last 12 months or during the screening period, and must be confirmed by a heart rhythm recording such as an ECG, which is a test that measures the electrical activity of your heart, Holter monitor, which is a portable device that records your heart rhythm, or any other heart recording method
You must have one or more of the following conditions at the screening visit: a measurement showing that your heart is in irregular rhythm at least 1 percent of the time on a portable heart monitor within the last 12 months, or a score of 2 or higher for males or 3 or higher for females on a CHA2DS2-VASc score, which is a scoring system that estimates your risk of stroke based on factors like heart failure, high blood pressure, age, diabetes, blood vessel disease, and prior stroke, or stable heart failure with mild symptoms classified as New York Heart Association class I or II, which means you have no or slight limitation of physical activity, or a blood test result showing an NT-proBNP level of 300 or higher, which is a marker that indicates stress on your heart, measured within the last 12 months
You must be receiving treatment to prevent stroke as recommended by medical guidelines, as confirmed by your doctor at the screening visit
You must have a body mass index greater than 18, which is a measure of body fat calculated from your weight and height
Your heart must be in sinus rhythm, which is a normal heart rhythm, at the baseline visit as shown by a 12-lead ECG. If you have persistent atrial fibrillation, you must undergo a procedure called cardioversion, which restores normal heart rhythm, at least 12 hours before joining the study

Who Cannot Join the Study?

No specific exclusion criteria have been provided in the available study information
Please note that this study is for patients with atrial fibrillation, which is an irregular and often rapid heart rhythm that can cause poor blood flow to the body
The study involves testing a treatment called PKN605 to see how it affects the amount of time patients experience atrial fibrillation
The study includes both male and female participants
The study accepts adults and elderly patients

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
University Hospital Maastricht	Maastricht	The Netherlands

Other Sites

Site Name	City	Country
Asklepios Klinik St George	Hamburg	Germany
Maxima Medisch Centrum	Veldhoven	The Netherlands
Velocity Clinical Research Luebeck GmbH	Luebeck	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Reinier de Graaf Groep	Delft	The Netherlands
Ulnsqopret Mljkkfl Cckbqy Hjqmndqpbsipwlcxx	Hamburg	Germany
Rggwfdupk Zujzqhzess Skkmilbyt	Arnhem	The Netherlands
Uytaygoinhme Mzibfml Czesbvj Gkbylviru	Groningen	The Netherlands
Aqarskjo Dl Rruffz Ztzdbzsvfb Bywc	Goes	The Netherlands
Zmlepam fsb kbxleyhml Scvwfej Bfu Hmiyytx	Bad Homburg	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	30.01.2026
The Netherlands	Recruiting	30.01.2026

Trial locations

PKN605 is an oral medication being tested in this clinical trial. It is being studied to see if it can reduce the amount of time participants experience atrial fibrillation, which is an irregular heart rhythm. The study will also look at how safe the medication is, how well participants tolerate it, and how the body processes it.

Placebo is an inactive substance that looks like the real medication but contains no active treatment. It is used as a comparison to help researchers understand if PKN605 is actually working or if any changes are due to other factors.

Atrial Fibrillation – Atrial fibrillation is a heart rhythm disorder where the upper chambers of the heart beat irregularly and often rapidly. Instead of contracting in a coordinated way, the atria quiver or fibrillate, which prevents them from pumping blood effectively into the lower chambers. This irregular rhythm occurs because electrical signals in the heart become disorganized. The condition can be persistent, meaning it lasts for extended periods, or it can come and go in episodes. During atrial fibrillation, the heart may beat too fast, too slow, or irregularly. The irregular heartbeat can lead to blood pooling in the heart chambers, which may cause various complications over time.

Trial ID:

2025-520518-79-00

Protocol code:

CPKN605A12201

Trial Phase:

Therapeutic exploratory (Phase II)

Other Trials to Consider

#1 Clinical Trials Search in Europe

A Study to Test How Well PKN605 Works and How Safe It Is in Patients with Atrial Fibrillation

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?