Recruiting
Phase 2

PKN605

Sponsor:

Novartis Pharmaceuticals

Code:

NCT07217067

Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PKN605

Placebo

Study Details

Brief summary:

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

Conditions

Atrial Fibrillation

Study ID

NCT07217067

Start date

Oct 28, 2025

Status verified date

Jul, 2026

Completion date

Sep 9, 2027

Anticipated

Primary completion date

Sep 9, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

165 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PKN605 lower dose

PKN605 is an oral formulation

experimental: PKN605 higher dose

PKN605 is an oral formulation

placebo comparator: Placebo

Placebo is an oral formulation

Interventions

PKN605

PKN605 is an oral formulation

Placebo

Matching placebo

Primary outcome measure

  • Atrial fibrillation burden from ECG patch monitors [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

1-888-669-6682novartis.email@novartis.com

Novartis Pharmaceuticals

+41613241111

Locations

Cardiology Associates of North MS

Recruiting

Tupelo, Mississippi, United States, 38801

Contacts

Brittany Cook

Brittany.cook@nmhs.net

Principal Investigator:

James Edgar Stone

Cooper University Hospital

Recruiting

Camden, New Jersey, United States, 08103

Contacts

Ifeoluwa Onuoha

+1 856 342 2000onuoha-ifeoluwa@cooperhealth.edu

Principal Investigator:

Andrea Russo

Weill Cornell Medical Center

Recruiting

New York, New York, United States, 10021

Contacts

Penn Collins

gpc4001@med.cornell.edu

Principal Investigator:

Jim Way Cheung

Duke Univ Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Jessalyn Davis

jessalyn.crews@duke.edu

Principal Investigator:

Jonathan Piccini

Intermountain Medical Center

Recruiting

Murray, Utah, United States, 84107

Contacts

Paden Hansen

paden.hansen@imail.org

Principal Investigator:

Michael Cutler

Swedish Heart and Vascular Clinic

Recruiting

Seattle, Washington, United States, 98122

Contacts

Serena Risher

+1 206 386 6462Serena.Risher@swedish.org

Principal Investigator:

David Lam

Novartis Investigative Site

Recruiting

Calgary, Alberta, Canada, T2P 3C5

Novartis Investigative Site

Recruiting

Vancouver, British Columbia, Canada, V5Z 1M9

Novartis Investigative Site

Recruiting

Halifax, Nova Scotia, Canada, B3H 3A7

Novartis Investigative Site

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

Novartis Investigative Site

Recruiting

London, Ontario, Canada, N6A 5W9

Novartis Investigative Site

Recruiting

Newmarket, Ontario, Canada, L3Y 2P6

Novartis Investigative Site

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Novartis Investigative Site

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Novartis Investigative Site

Recruiting

Montreal, Quebec, Canada, H1T 1C8

Novartis Investigative Site

Recruiting

Montreal, Quebec, Canada, H2X 1R9

Novartis Investigative Site

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Novartis Investigative Site

Recruiting

Québec, Quebec, Canada, G1V 4G5

Novartis Investigative Site

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Jul 31, 2026

Last verified

Jul, 2026

Keywords

  • Atrial fibrillation
  • Atrial fibrillation burden
  • Arrhythmia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-07-31.