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

Last updated: January 23, 2026
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

2

Condition

Dysrhythmia

Circulation Disorders

Atrial Fibrillation

Treatment

PKN605

Placebo

Clinical Study ID

NCT07217067
CPKN605A12201
  • Ages > 18
  • All Genders

Study Summary

A randomized, placebo-controlled, participant-and investigator-blinded study to evaluate the efficacy in reducing atrial fibrillation burden as well as the safety, tolerability and pharmacokinetics of PKN605 in participants with atrial fibrillation

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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

  • 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 anyother 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, ECGpatch monitor, or other ambulatory electrocardiographic monitor within the last 12months

  • CHA2DS2-VASc score of 2 or higher in males, 3 or higher in females (1 point forcongestive heart failure, hypertension, age 65-74 years, diabetes, vascular disease,female sex; 2 points for age 75 years or older, prior stroke or transient ischemicattack)

  • 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 theInvestigator

  • Participants must have a body mass index (BMI) ≥ 18 kg/m2. BMI is calculated asbody weight (kg) divided by height (m) squared

  • Inclusions at Day 1

  • Sinus rhythm at Baseline documented by 12-lead ECG (participants withpersistent AF should be cardioverted at least 12 hours before randomization)

Exclusion

Exclusion Criteria:

-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 IIIanti-arrhythmic therapy must be discontinued at least 7 days before Screening phaseECG patch monitor; amiodarone must be discontinued at least 6 weeks before Screeningphase ECG patch monitor)

  • History of an AF ablation procedure within the last 6 months without a recurrence ofAF 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 12months, or during Screening

  • Current decompensated heart failure or hospitalization for heart failure within 3months prior to Screening

Study Design

Total Participants: 165
Treatment Group(s): 2
Primary Treatment: PKN605
Phase: 2
Study Start date:
October 28, 2025
Estimated Completion Date:
September 09, 2027

Study Description

A screening period of up to 90 days will be conducted to determine participants' eligibility. Once eligibility is confirmed, participants will be randomly assigned to receive either PKN605 or placebo. The treatment phase will last for 24 weeks, during which participants will visit the clinic approximately once a month. During the study, participants' atrial fibrillation will be monitored using various ECG devices. Approximately one month after the end of the treatment phase, participants will have a final safety follow-up visit. The primary purpose of the study is to monitor the effect PKN605 has on the amount of time participants spend in atrial fibrillation.

Connect with a study center

  • Novartis Investigative Site

    London 6058560, Ontario 6093943 N6A 5W9
    Canada

    Active - Recruiting

  • Novartis Investigative Site

    Newmarket 6087701, Ontario 6093943 L3Y 2P6
    Canada

    Active - Recruiting

  • Novartis Investigative Site

    Toronto 6167865, Ontario 6093943 M5B 1W8
    Canada

    Active - Recruiting

  • Novartis Investigative Site

    Montreal 6077243, Quebec 6115047 H1T 1C8
    Canada

    Active - Recruiting

  • Novartis Investigative Site

    Québec 6325494, Quebec 6115047 G1V 4G5
    Canada

    Active - Recruiting

  • Novartis Investigative Site

    Sherbrooke 6146143, Quebec 6115047 J1H 5N4
    Canada

    Active - Recruiting

  • Novartis Investigative Site

    Beijing 1816670, Beijing Municipality 2038349 100013
    China

    Active - Recruiting

  • Novartis Investigative Site

    Xi'an 1790630, 223001
    China

    Active - Recruiting

  • Novartis Investigative Site

    Bad Homburg 2953436, 61348
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Berlin 2950159, 10787
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Hamburg 2911298, 20246
    Germany

    Active - Recruiting

  • Novartis Investigative Site

    Delft 2757345, South Holland 2743698 2625 AD
    Netherlands

    Active - Recruiting

  • Novartis Investigative Site

    Goes 2755476, Zeeland 2744011 4462 RA
    Netherlands

    Active - Recruiting

  • Novartis Investigative Site

    Veldhoven 2745706, 5504 DB
    Netherlands

    Active - Recruiting

  • Novartis Investigative Site

    Singapore 1880252, 119074
    Singapore

    Active - Recruiting

  • Novartis Investigative Site

    Brighton 2654710, East Sussex BN2 5BE
    United Kingdom

    Active - Recruiting

  • Novartis Investigative Site

    London 2643743, W12 0HS
    United Kingdom

    Active - Recruiting

  • Cardiology Associates of North MS

    Tupelo 4448903, Mississippi 4436296 38801
    United States

    Active - Recruiting

  • Weill Cornell Medical Center

    New York 5128581, New York 5128638 10021
    United States

    Active - Recruiting

  • Intermountain Medical Center

    Murray 5778755, Utah 5549030 84107
    United States

    Active - Recruiting

  • Swedish Heart and Vascular Clinic

    Seattle 5809844, Washington 5815135 98122
    United States

    Active - Recruiting

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