PKN605 for Atrial Fibrillation

Recruiting at 6 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Novartis Pharmaceuticals

Must be taking: Stroke prevention

Must not be taking: Antiarrhythmics

Disqualifiers: Permanent AF, Pacemaker, Cardiomyopathy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 24 weeks

165 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new oral medication, PKN605, to determine if it can reduce the frequency of atrial fibrillation (AF), an irregular and often rapid heart rate. The trial compares two different doses of PKN605 against a placebo to assess its effectiveness and safety. It seeks participants who have experienced at least two episodes of AF, with one occurring within the past year, and who are already on stroke prevention treatment. Participants should not have a pacemaker or certain heart conditions, nor should they be on specific heart rhythm medications. For those whose daily life is affected by AF, this trial offers an opportunity to explore a new treatment option. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications for the trial?

You will need to stop using certain antiarrhythmic medications (drugs that help control irregular heartbeats) before joining the trial. Specifically, Vaughan Williams class I or III anti-arrhythmic drugs must be stopped at least 7 days before the screening, and amiodarone must be stopped at least 6 weeks before the screening.

Is there any evidence suggesting that PKN605 is likely to be safe for humans?

Research has shown that PKN605 appears safe for people with atrial fibrillation. In earlier studies, participants reported no serious side effects, suggesting the treatment is generally well-tolerated. Although more research is needed to fully understand its safety, current evidence suggests that PKN605 could offer a new treatment option for atrial fibrillation. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for atrial fibrillation?

Researchers are excited about PKN605 for atrial fibrillation because it offers a potentially new way to manage this common heart condition. Unlike typical treatments such as beta-blockers, calcium channel blockers, or anticoagulants, PKN605 is an oral formulation that could provide a more targeted approach. The drug is being tested in both lower and higher doses to see how effective it can be at different levels. This could mean more personalized treatment options for patients, potentially leading to better outcomes with fewer side effects.

What evidence suggests that PKN605 might be an effective treatment for atrial fibrillation?

Research has shown that PKN605 might reduce the duration of atrial fibrillation (an irregular heartbeat). Earlier studies examined its effect on the length of atrial fibrillation, which is crucial for assessing its efficacy. Initial results suggested that this treatment could lessen the impact of atrial fibrillation and help maintain a steady heart rhythm. However, more data is needed to confirm these effects. This trial tests PKN605 at different doses to evaluate its effectiveness and safety at various levels. ^{1 2 3 4 6}

Who Is on the Research Team?

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for adults with atrial fibrillation who have a moderate to high stroke risk based on their CHA2DS2-VASc score, stable heart failure symptoms, and at least two episodes of AF in the past year. They must not be severely overweight or underweight and should have had an elevated NT-proBNP level recently.

Inclusion Criteria

My CHA2DS2-VASc score is high enough to qualify.

My heart condition is stable or only mildly affects my daily activities.

I meet the requirements listed for the screening phase.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

up to 12 weeks

Treatment

Participants receive either PKN605 or placebo for 24 weeks, with monthly clinic visits and atrial fibrillation monitoring using ECG devices

24 weeks

6 visits (in-person, monthly)

Follow-up

Participants have a final safety follow-up visit approximately one month after the end of the treatment phase

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• PKN605

Trial Overview The study tests PKN605's ability to reduce atrial fibrillation burden against a placebo. Participants won't know which one they're getting. The trial also looks at how safe and tolerable PKN605 is, as well as how it moves through the body.

How Is the Trial Designed?

Group I: PKN605 lower dose Experimental Treatment 1 Intervention

PKN605 is an oral fomulation

Group II: PKN605 higher dose Experimental Treatment 1 Intervention

PKN605 is an oral formulation

Group III: Placebo Placebo Group 1 Intervention

Placebo is an oral formulation

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07217067

NCT07217067 | A Study to Investigate the Efficacy, Safety, ... The primary purpose of the study is to monitor the effect PKN605 has on the amount of time participants spend in atrial fibrillation.

2. withpower.com withpower.com/trial/phase-2-arrhythmias-cardiac-9-2025-acc8e

PKN605 for Atrial Fibrillation · Info for Participants This trial is for adults with atrial fibrillation who have a moderate to high stroke risk based on their CHA2DS2-VASc score, stable heart failure symptoms, and ...

3. ichgcp.net ichgcp.net/clinical-trials-registry/556125-a-study-to-investigate-the-efficacy-safety-tolerability-and-pharmacokinetics-of-pkn605-in-participants-with-atrial-fibrillation

Clinical Trial for Atrial Fibrillation Treatment with Investigational Drug ... This study aims to determine whether PKN605 can effectively reduce the amount of time participants spend in atrial fibrillation while also assessing the ...

4. synapse.patsnap.com synapse.patsnap.com/drug/a72483f3118e46c68aa610af7c60418b

PKN605 - Drug Targets, Indications, Patents A Randomized, Placebo-controlled, Participant- and Investigator-blinded Study to Evaluate the Efficacy in Reducing Atrial Fibrillation ...

5. academic.oup.com academic.oup.com/europace/article/27/8/euaf076/8100306

Practical compendium of antiarrhythmic drugs: a clinical ... The compendium highlights persistent challenges in arrhythmia treatment, including clinical constraints, procedural risks, and the complexity of certain ...

6. meddatax.com meddatax.com/clinical-trials/NCT07217067

A Study to Investigate the Efficacy, Safety, Tolerability and ... A Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of PKN605 in Participants With Atrial Fibrillation ... safety data for this trial ...