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

Trial details

Who runs it

Novartis Pharmaceuticals

Trial code

NCT07217067

Record updated

28 October 2026

Original description

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 fibrillationRead 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

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

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 atrial fibrillation; AF (atrial fibrillation or atrial flutter) within the last 12 months (or during screening) documented by 12-lead ECG, Holter, or any other ECG recording method, as confirmed by the Investigator; Meets one or more of the following criteria:; Recurrent AF (≥ 2 episodes), and ≥ 1 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 B. AFB ≥ 1% or an AF episode lasting ≥ 2 h during Screening, including when detected using a study provided ECG patch monitor C. Persistent AF, as confirmed by the Investigator; 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: 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); Current decompensated heart failure or hospitalization for heart failure within 3 months prior to Screening; Ongoing reversible causes of AF (e.g., hyperthyroidism, myocarditis, acute alcohol, 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 Screening. If multiple LVEF measurements are recorded within the last 12 months, the most recent LVEF measurement should be used; -Exclusions at Screening; Permanent AF; Infiltrative (e.g., amyloidosis, sarcoidosis) or hypertrophic cardiomyopathy.

ClinicalTrials.gov NCT07217067