RecruitingPHASE2INTERVENTIONAL

A Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of PKN605 in Participants With Atrial Fibrillation

This research study is looking into a new medication, PKN605, for individuals affected by atrial fibrillation – a condition causing an irregular heartbeat. The main goal is to understand if PKN605 can effectively reduce how much time people spend in atrial fibrillation. Researchers will also be checking for any side effects and how well the body handles the new medicine. Participants will be randomly given either PKN605 or a dummy medicine (placebo) and will be closely monitored. This is a "Phase 2" study, meaning it's an early step in testing the medicine after initial safety checks, focusing on its effectiveness and continued safety.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Novartis Pharmaceuticals

Enrolment target

165

Start

28 Oct 2025

Estimated completion

09 Sep 2027

Atrial Fibrillation

What is this study about?

This study is investigating a new medication called PKN605 for people who have atrial fibrillation. Atrial fibrillation is a common heart condition where the heart beats irregularly. This can sometimes lead to uncomfortable symptoms and other health problems if not managed. The main purpose of this study is to see if PKN605 can help reduce the amount of time people's hearts are in an irregular rhythm.

Researchers will also be carefully watching for any side effects or problems with PKN605 to make sure it's safe. They will also be learning how the body processes the medication. By comparing PKN605 to a "placebo" (a dummy medicine with no active ingredients), the researchers can get a clear picture of the new medicine's effects. Neither you nor your study doctor will know whether you are receiving PKN605 or the placebo, which helps ensure the results are fair.

This is a 'Phase 2' study, which means PKN605 has already been tested in smaller groups of people and found to be generally safe. Now, the focus is on understanding how well it works and continuing to monitor safety in a larger group of people with atrial fibrillation.

Key takeaways

This study is testing a new medicine (PKN605) for atrial fibrillation.
It aims to see if PKN605 reduces irregular heartbeats and is safe.
You'll either receive PKN605 or a dummy medicine (placebo).
Participation includes regular clinic visits and heart monitoring over several months.
The study helps researchers understand and possibly improve AF treatment.

Who may be eligible?

To join this study, you need to be at least 18 years old. You must have had at least two episodes of atrial fibrillation (or a related condition called atrial flutter), with at least one confirmed atrial fibrillation episode in the last year. Your doctor would have confirmed this using an ECG recording.

There are also some other specific health requirements, such as a particular score on a risk assessment tool for stroke (CHA2DS2-VASc score), or stable heart failure, or specific blood test results. You should also be taking standard medication to prevent strokes if that applies to you, and your body weight needs to be within a certain range. At the start of the treatment, your heart should be in a normal rhythm.

You won't be able to join if you have 'permanent atrial fibrillation' (where your heart is always in an irregular rhythm) or if your atrial fibrillation is caused by other temporary health problems like an overactive thyroid or an infection. Also, if you are currently taking certain types of heart rhythm medications, you might need to stop them for a period before joining the study.

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?
Have you had at least two episodes of irregular heartbeat (AFib), with one in the last year?
Are you taking medication to prevent strokes, if your doctor recommends it?
Is your heart in a normal rhythm right before starting treatment?
Do you not have permanent atrial fibrillation?

Answer every question to see your result.

What does participation involve?

If you decide to take part, there will be a screening period of up to 90 days to check if the study is right for you. If you qualify, you will be randomly assigned to receive either the study medicine (PKN605) or a placebo. You won't know which one you are getting, and neither will your study doctor.

The main treatment part of the study will last for about 24 weeks (roughly 6 months). During this time, you will visit the clinic about once a month. Your heart rhythm will be checked regularly using different ECG devices to monitor your atrial fibrillation. After the 24-week treatment period, there will be one final safety check-up visit about a month later. The total duration of your involvement, including screening and follow-up, could be up to 9-10 months.

Potential risks and benefits

Participating in this study might mean you receive a new medicine that could potentially help manage your atrial fibrillation, or you might help researchers learn more about your condition. However, there's no guarantee you will personally benefit, as you might receive the placebo or the new medicine may not work for you. There could be side effects from PKN605, some of which might be serious, and these will be carefully monitored. You will receive close medical attention throughout the study, which could be beneficial. Remember, taking part in any clinical trial is entirely voluntary, and you have the right to withdraw at any time for any reason without it affecting your usual medical care.

Locations (38)

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

Cardiology Associates of North MS
Verified postcode
Tupelo, United States· Recruiting
Weill Cornell Medical Center
Verified postcode
New York, United States· Recruiting
Duke Univ Medical Center
Verified postcode
Durham, United States· Recruiting
Intermountain Medical Center
Verified postcode
Murray, United States· Recruiting
Swedish Heart and Vascular Clinic
Verified postcode
Seattle, United States· Recruiting
Novartis Investigative Site
Verified postcode
Calgary, Canada· Recruiting
Novartis Investigative Site
Verified postcode
Vancouver, Canada· Recruiting
Novartis Investigative Site
Verified postcode
Hamilton, Canada· Recruiting
Novartis Investigative Site
Verified postcode
London, Canada· Recruiting
Novartis Investigative Site
Verified postcode
Newmarket, Canada· Recruiting
Novartis Investigative Site
Verified postcode
Toronto, Canada· Recruiting
Novartis Investigative Site
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is atrial fibrillation?

Atrial fibrillation is a common heart condition that causes an irregular and often fast heart rate, making your heart flutter or beat too quickly.

What does 'randomized' mean?

It means you'll be assigned to either the study medicine group or the placebo (dummy medicine) group by chance, like flipping a coin. Neither you nor the doctors will choose.

What is a placebo?

A placebo is a 'dummy' medicine that looks like the study drug but contains no active ingredients. It helps researchers understand if the new drug is truly making a difference.

What is 'Phase 2' of a study?

Phase 2 studies are early stages where researchers test a new medicine on a larger group of people to see if it works and to continue monitoring its safety and side effects.

Will I know if I'm getting the real medicine or the placebo?

No, you won't know, and neither will your study doctor. This is called 'blinded' and helps keep the study fair and unbiased.

How to find out more

Novartis Pharmaceuticals

novartis.email@novartis.com 1-888-669-6682 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.