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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Atrial fibrillation burden from ECG patch monitors — 24 weeks Defined as the amount of time spent in atrial fibrillation as a proportion of the analyzable monitoring time
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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