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

NCT07217067

RecruitingPhase 2

Sponsor: Novartis Pharmaceuticals

Conditions: Atrial Fibrillation

Interventions: PKN605, Placebo

Countries: United States, Canada, China, Germany, Netherlands, Singapore, United Kingdom

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 overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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
Locations (40)
  • Tupelo, Mississippi, United States
  • Camden, New Jersey, United States
  • New York, New York, United States
  • Durham, North Carolina, United States
  • Murray, Utah, United States
  • Seattle, Washington, United States
  • Calgary, Alberta, Canada
  • Vancouver, British Columbia, Canada
  • Halifax, Nova Scotia, Canada
  • Hamilton, Ontario, Canada
  • London, Ontario, Canada
  • Newmarket, Ontario, Canada
  • Toronto, Ontario, Canada
  • Toronto, Ontario, Canada
  • Montreal, Quebec, Canada
  • Montreal, Quebec, Canada
  • Montreal, Quebec, Canada
  • Québec, Quebec, Canada
  • Sherbrooke, Quebec, Canada
  • Beijing, Beijing Municipality, China
  • Beijing, China
  • Xi'an, China
  • Bad Homburg, Germany
  • Berlin, Germany
  • Berlin, Germany
  • Hamburg, Germany
  • Hamburg, Germany
  • Arnhem, Gelderland, Netherlands
  • Maastricht, Limburg, Netherlands
  • Delft, South Holland, Netherlands
  • + 10 more on CT.gov