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

A vizsgálat adatai

Ki végzi

Novartis Pharmaceuticals

Azonosító

NCT07217067

A regiszteradat frissítve

2026. október 28.

Eredeti leírás

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 fibrillationA teljes eredeti leírásKevesebb

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

Bevonási feltételek: -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).

Kizáró feltételek: 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