A study to investigate the efficacy, safety, tolerability and pharmacokinetics of PKN605 in participants with atrial fibrillation
Key facts
- Where
- Arnhem, Delft, Goes, Groningen, Haarlem, Maastricht és Veldhoven, HollandiaSee the 7 sites
- Phase
- 2. fázis
Where in Hollandia
- Rijnstate Ziekenhuis StichtingArnhem, HollandiaTaking people
- Reinier de Graaf GroepDelft, HollandiaTaking people
- Admiraal De Ruyter Ziekenhuis B.V.Goes, HollandiaTaking people
- Universitair Medisch Centrum GroningenGroningen, HollandiaTaking people
- Spaarne Gasthuis StichtingHaarlem, HollandiaTaking people
- Academisch Ziekenhuis MaastrichtMaastricht, HollandiaTaking people
- Maxima Medisch CentrumVeldhoven, HollandiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novartis Pharma AG
- Trial code
- EU 2025-520518-79-00
- Record updated
- 2026. október 12.
- Original description
To evaluate the effect of PKN605 on atrial fibrillation burdenRead full original descriptionShow less
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
To evaluate the effect of PKN605 on atrial fibrillation burden
Inclusion: 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 fibrilation; At least one 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, at Screening: • 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, 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, at Screening; Participants must have a body mass index (BMI) >18 kg/m2. BMI is calculated as body weight (kg) divided by height in (m) squared; Sinus rhythm at Baseline as documented by a 12-lead ECG (participants with persistent AF should be cardioverted at least 12 hours before randomization).
Exclusion: Ongoing use of antiarrhythmic therapy (Vaughan Williams class l 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); Current decompensated heart failure or hospitalization for heart failure within 3 months prior to Screening; Ongoing reversible causes of AF (e.g., hyperthyroidism, myocarditis, alcohol use, sepsis- or infection-related AF, surgery-related AF, pulmonary embolism); 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; Left ventricular ejection fraction of 40% or less documented within the last 12 months, or during the Screening period. If multiple LVEF measurements are recorded within last 12 months, the most recent LVEF measurement should be used; Permanent AF; Infiltrative (e.g., amyloidosis, sarcoidosis) or hypertrophic cardiomyopathy.