PKN605 for reducing atrial fibrillation burden

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with documented atrial fibrillation will be screened for up to 90 days and then randomly assigned in a participant- and investigator-blinded fashion to receive PKN605 or matching placebo. The treatment phase lasts 24 weeks with roughly monthly clinic visits and continuous or intermittent ECG monitoring (Holter, patch, or mobile telemetry) to quantify atrial fibrillation burden. Safety, tolerability, and pharmacokinetics will be followed during treatment and with a final safety visit about one month after the treatment phase ends. The primary outcome is change in the percentage of time spent in atrial fibrillation during the treatment period.

Why it matters

Who can join: the full rules

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 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:

A. 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 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

Where it's running

• Cardiology Associates of North MS
  Tupelo, Mississippi, United States Recruiting
• Cooper University Hospital
  Camden, New Jersey, United States Recruiting
• Weill Cornell Medical Center
  New York, New York, United States Recruiting
• Duke Univ Medical Center
  Durham, North Carolina, United States Recruiting
• Intermountain Medical Center
  Murray, Utah, United States Recruiting
• Swedish Heart and Vascular Clinic
  Seattle, Washington, United States Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.