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PKN605 for Atrial Fibrillation Study

This study is testing a new oral medication called PKN605 for people with atrial fibrillation (a type of irregular heartbeat). We want to see if PKN605 can reduce how often and how long you experience atrial fibrillation episodes. Participants will be randomly assigned to receive either PKN605 or a placebo (an inactive substance) for 24 weeks. We'll also be looking at the safety and how well your body handles PKN605. You might be able to join if you are 18 or older and have had at least two episodes of atrial fibrillation, with one happening recently. The current recruitment status is unclear.

Study design
This is a randomized, placebo-controlled study where neither you nor the study team will know if you are receiving PKN605 or the placebo. It plans to include 165 participants.
What's involved
You will have a screening period of up to 90 days, followed by 24 weeks of treatment. During treatment, you will visit the clinic about once a month, and your heart rhythm will be monitored with ECG devices.
Compensation
Not stated in the trial record.
Follow-up
You will have a final safety follow-up visit approximately one month after the 24-week treatment phase ends.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07217067

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Novartis Pharmaceuticals
~165 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:PKN605Placebo

At a glance

Recruiting sites
39 of 40 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Atrial fibrillation burden from ECG patch monitors
Measured over 24 weeks

Conditions

Atrial Fibrillation

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Atrial Fibrillation

NCT07217067

Where you'd take part

This study runs at 40 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Cardiology Associates of North MS

    Tupelo, Mississippistudy coordinator listed

    Recruiting

  • Cooper University Hospital

    Camden, New Jerseystudy coordinator listed

    Recruiting

  • Duke Univ Medical Center

    Durham, North Carolinastudy coordinator listed

    Recruiting

  • Intermountain Medical Center

    Murray, Utahstudy coordinator listed

    Recruiting

  • Swedish Heart and Vascular Clinic

    Seattle, Washingtonstudy coordinator listed

    Recruiting

  • Weill Cornell Medical Center

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Novartis Investigative Site

    Calgary, Alberta, Canadano site contact published

    Recruiting

  • Novartis Investigative Site

    Vancouver, British Columbia, Canadano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals

Who to contact

Novartis Pharmaceuticals
[email protected]
1-888-669-6682
Email the study team

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Eligibility criteria

Inclusion

Inclusions at Screening
Signed informed consent must be obtained prior to participation in the study
Male and female participants ≥ 18 years of age
History of at least 2 episodes of AF (atrial fibrillation or atrial flutter), at least one episode must be atrial fibrillation
At least 1 of the AF episodes specified in inclusion #3 must be within the last 12 months (or during screening) and documented by 12-lead ECG, Holter, or any other ECG recording method, as confirmed by the Investigator
One or more of the following:
AFB of 1% or higher on a local ambulatory Holter, mobile cardiac telemetry, ECG patch monitor, or other ambulatory electrocardiographic monitor within the last 12 months
CHA2DS2-VASc score of 2 or higher in males, 3 or higher in females (1 point for congestive heart failure, hypertension, age 65-74 years, diabetes, vascular disease, female sex; 2 points for age 75 years or older, prior stroke or transient ischemic attack)
Stable heart failure or with New York Heart Association class I or II symptoms
NT-proBNP level of 300 pg/mL or higher on a local lab test within the last 12 months
On guideline-directed stroke prevention treatment, as confirmed by the Investigator
Participants must have a body mass index (BMI) ≥ 18 kg/m2. BMI is calculated as body weight (kg) divided by height (m) squared
Inclusions at Day 1
Sinus rhythm at Baseline documented by 12-lead ECG (participants with persistent AF should be cardioverted at least 12 hours before randomization)

Exclusion

Exclusions at Screening
Permanent AF
Ongoing reversible causes of AF (e.g., hyperthyroidism, myocarditis, acute alcohol, sepsis- or infection related AF, surgery-related AF, pulmonary embolism)
Ongoing use of antiarrhythmic therapy (Vaughan Williams class I or III anti-arrhythmic therapy must be discontinued at least 7 days before Screening phase ECG patch monitor; amiodarone must be discontinued at least 6 weeks before Screening phase ECG patch monitor)
History of an AF ablation procedure without a recurrence of AF at least 2 or more months after the ablation.
Implanted pacemaker, defibrillator, or cardiac monitor
Infiltrative (e.g., amyloidosis, sarcoidosis) or hypertrophic cardiomyopathy
Left ventricular ejection fraction of 40% or less documented within the last 12 months, or during Screening. If multiple LVEF measurements are recorded within the last 12 months, the most recent LVEF measurement should be used
Current decompensated heart failure or hospitalization for heart failure within 3 months prior to Screening

What this trial measures

  • Atrial fibrillation burden from ECG patch monitors24 weeks

    Defined as the amount of time spent in atrial fibrillation as a proportion of the analyzable monitoring time