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PKN605 for reducing atrial fibrillation burden

A Randomized, Placebo-controlled, Participant- and Investigator-blinded Study to Evaluate the Efficacy in Reducing Atrial Fibrillation Burden (AFB) as Well as the Safety, Tolerability, and Pharmacokinetics of Oral PKN605 in Participants With Atrial Fibrillation

Phase 2 Interventional Novartis · NCT07217067

This trial will test whether the experimental drug PKN605 can reduce the amount of time adults with atrial fibrillation spend in irregular heart rhythm compared with placebo.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment165 (estimated)
Ages18 Years and up
SexAll
SponsorNovartis Industry-sponsored
Locations38 sites (Tupelo, Mississippi and 37 other locations)
Trial IDNCT07217067 on ClinicalTrials.gov

What this trial studies

Adults with documented atrial fibrillation will be screened for up to 90 days and then randomly assigned in a participant- and investigator-blinded fashion to receive PKN605 or matching placebo. The treatment phase lasts 24 weeks with roughly monthly clinic visits and continuous or intermittent ECG monitoring (Holter, patch, or mobile telemetry) to quantify atrial fibrillation burden. Safety, tolerability, and pharmacokinetics will be followed during treatment and with a final safety visit about one month after the treatment phase ends. The primary outcome is change in the percentage of time spent in atrial fibrillation during the treatment period.

Who should consider this trial

Good fit: Adults 18 or older with at least two prior AF episodes (one confirmed AF within the past 12 months) and evidence of AF burden ≥1% or qualifying CHA2DS2-VASc scores are the intended participants.

Not a fit: People without recent documented AF, with very low AF burden, or with contraindications to the investigational drug are unlikely to gain benefit from participation.

Why it matters

Potential benefit: If successful, PKN605 could lower AF burden and thereby reduce symptoms, emergency visits, or the need for additional procedures.

How similar studies have performed: Existing antiarrhythmic drugs and catheter ablation have reduced AF burden in other studies, but PKN605 is a novel investigational agent and this randomized phase 2 test represents early clinical data for this compound.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 (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 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 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

Where this trial is running

Tupelo, Mississippi and 37 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Atrial FibrillationAtrial fibrillationAtrial fibrillation burdenArrhythmia
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.