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Atrial FibrillationPhase 2NCT07217067

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

A Phase 2 study testing PKN605 in people with Atrial Fibrillation, run by Novartis Pharmaceuticals at 40 sites in 7 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation
What is being tested?
PKN605
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
165 participants
Where
40 sitesin 7 countries
Study dates
28 Oct 2025to 9 Sep 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • -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:
Show all 15Show fewer
  • 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)

Who cannot join

  • -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
Show all 9Show fewer
  • 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

Trial locations and contacts

40 sites in 7 countries. Contact the study team or a site near you to ask about taking part.

Novartis Pharmaceuticals contact

1-888-669-6682

novartis.email@novartis.com

Novartis Pharmaceuticals contact

+41613241111

40 sites in 7 countries

Canada13 sites, 13 recruiting

  • Novartis Investigative Site

    Calgary, Alberta, T2P 3C5

    Recruiting

  • Novartis Investigative Site

    Halifax, Nova Scotia, B3H 3A7

    Recruiting

  • Novartis Investigative Site

    Hamilton, Ontario, L8L 2X2

    Recruiting

  • Novartis Investigative Site

    London, Ontario, N6A 5W9

    Recruiting

  • Novartis Investigative Site

    Montreal, Quebec, H1T 1C8

    Recruiting

  • Novartis Investigative Site

    Montreal, Quebec, H2X 1R9

    Recruiting

  • Novartis Investigative Site

    Montreal, Quebec, H4A 3J1

    Recruiting

  • Novartis Investigative Site

    Newmarket, Ontario, L3Y 2P6

    Recruiting

  • Novartis Investigative Site

    Québec, Quebec, G1V 4G5

    Recruiting

  • Novartis Investigative Site

    Sherbrooke, Quebec, J1H 5N4

    Recruiting

  • Novartis Investigative Site

    Toronto, Ontario, M4N 3M5

    Recruiting

  • Novartis Investigative Site

    Toronto, Ontario, M5B 1W8

    Recruiting

  • Novartis Investigative Site

    Vancouver, British Columbia, V5Z 1M9

    Recruiting

Other trials in Canada

United States6 sites, 6 recruiting

  • Cooper University Hospital

    Camden, New Jersey, 08103

    Ifeoluwa Onuoha, onuoha-ifeoluwa@cooperhealth.edu

    Andrea Russo

    Recruiting

  • Duke Univ Medical Center

    Durham, North Carolina, 27710

    Jessalyn Davis, jessalyn.crews@duke.edu

    Jonathan Piccini

    Recruiting

  • Intermountain Medical Center

    Murray, Utah, 84107

    Paden Hansen, paden.hansen@imail.org

    Michael Cutler

    Recruiting

  • Weill Cornell Medical Center

    New York, New York, 10021

    Penn Collins, gpc4001@med.cornell.edu

    Jim Way Cheung

    Recruiting

  • Swedish Heart and Vascular Clinic

    Seattle, Washington, 98122

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

    David Lam

    Recruiting

  • Cardiology Associates of North MS

    Tupelo, Mississippi, 38801

    Brittany Cook, Brittany.cook@nmhs.net

    James Edgar Stone

    Recruiting

Other trials in United States

Netherlands6 sites, 5 recruiting

  • Novartis Investigative Site

    Arnhem, Gelderland, 6815 AD

    Recruiting

  • Novartis Investigative Site

    Delft, South Holland, 2625 AD

    Withdrawn

  • Novartis Investigative Site

    Goes, Zeeland, 4462 RA

    Recruiting

  • Novartis Investigative Site

    Groningen, 9713 GZ

    Recruiting

  • Novartis Investigative Site

    Maastricht, Limburg, 6229 HX

    Recruiting

  • Novartis Investigative Site

    Veldhoven, 5504 DB

    Recruiting

Other trials in Netherlands

Germany5 sites, 5 recruiting

  • Novartis Investigative Site

    Bad Homburg, 61348

    Recruiting

  • Novartis Investigative Site

    Berlin, 10787

    Recruiting

  • Novartis Investigative Site

    Berlin, 13353

    Recruiting

  • Novartis Investigative Site

    Hamburg, 20099

    Recruiting

  • Novartis Investigative Site

    Hamburg, 20246

    Recruiting

Other trials in Germany

United Kingdom4 sites, 3 recruiting

  • Novartis Investigative Site

    Brighton, East Sussex, BN2 5BE

    Recruiting

  • Novartis Investigative Site

    Liverpool, L14 3PE

    Withdrawn

  • Novartis Investigative Site

    London, W12 0HS

    Recruiting

  • Novartis Investigative Site

    Newcastle upon Tyne, Tyne and Wear, NE7 7DN

    Recruiting

Other trials in United Kingdom

China3 sites, 3 recruiting

  • Novartis Investigative Site

    Beijing, Beijing Municipality, 100013

    Recruiting

  • Novartis Investigative Site

    Beijing, 100730

    Recruiting

  • Novartis Investigative Site

    Xi'an, 223001

    Recruiting

Other trials in China

Singapore3 sites, 3 recruiting

  • Novartis Investigative Site

    Singapore, Singapore, 308433

    Recruiting

  • Novartis Investigative Site

    Singapore, 119074

    Recruiting

  • Novartis Investigative Site

    Singapore, 169609

    Recruiting

Other trials in Singapore

About this study

Official title: 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

Read the detailed description

A screening period of up to 90 days will be conducted to determine participants' eligibility. Once eligibility is confirmed, participants will be randomly assigned to receive either PKN605 or placebo. The treatment phase will last for 24 weeks, during which participants will visit the clinic approximately once a month. During the study, participants' atrial fibrillation will be monitored using various ECG devices. Approximately one month after the end of the treatment phase, participants will have a final safety follow-up visit. The primary purpose of the study is to monitor the effect PKN605 has on the amount of time participants spend in atrial fibrillation.

Being tested
PKN605, Placebo
Keywords
Atrial fibrillation, Atrial fibrillation burden, Arrhythmia
Medical subject headings
Atrial Fibrillation, Arrhythmias, Cardiac

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PKN605Drug

    PKN605 is an oral formulation

  • PlaceboOther

    Matching placebo

Study groups in NCT07217067
Study groupRoleWhat they receive
PKN605 lower doseExperimentalPKN605 is an oral formulation
Receives: Drug: PKN605
PKN605 higher doseExperimentalPKN605 is an oral formulation
Receives: Drug: PKN605
PlaceboPlacebo comparatorPlacebo is an oral formulation
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Atrial fibrillation burden from ECG patch monitors

    Defined as the amount of time spent in atrial fibrillation as a proportion of the analyzable monitoring time

    Measured: 24 weeks

Secondary outcomes (3)

  1. Time from the date of randomization to first atrial fibrillation recurrence

    Defined as the time (days) from the date of randomization to first atrial fibrillation recurrence

    Measured: 24 weeks

  2. Presence of atrial fibrillation recurrence after randomization

    Defined as presence of (or absence) of atrial fibrillation recurrence after randomization detected by ECG patch monitor, 12-lead ECG, handheld ECG, or other protocol approved method for ascertainment individually and as a composite

    Measured: 24 weeks

  3. Pharmacokinetic Parameter: concentration

    PKN605 plasma concentration

    Measured: 24 Weeks ( 0 hour(Pre-dose), 2 and 4 hour post dose)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Oct 2025
  2. Study start28 Oct 2025
  3. Primary completion9 Sep 2027 (estimated)
  4. Study completion9 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
165 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07217067
Sponsor's protocol ID
CPKN605A12201
Status last verified
Oct 2026
First submitted
14 Oct 2025
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PKN605 in people with Atrial Fibrillation, run by Novartis Pharmaceuticals at 40 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in Canada, United States, Netherlands, Germany, United Kingdom and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Atrial fibrillation burden from ECG patch monitors (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07217067.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

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