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New pill aims to tame irregular heartbeat in atrial fibrillation patients

NCT ID NCT07217067

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This Phase 2 trial tests an oral drug called PKN605 in 165 adults with atrial fibrillation. Participants are randomly assigned to receive either the drug or a placebo, and neither they nor their doctors know which they get. The main goal is to see if PKN605 reduces the amount of time spent in atrial fibrillation, as measured by ECG patch monitors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PKN605 (oral drug)
What this could lead to
If it works, this could lead to a new daily pill that helps control atrial fibrillation and reduces the time spent in irregular heart rhythm.
What could go wrong
This is an early Phase 2 trial with only 165 participants, so results may not apply to everyone. The drug may not reduce AF burden more than placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 165 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Arrhythmias, Cardiac atrial fibrillation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial fibrillation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    39 sites in 7 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cardiology Associates of North MS

    RECRUITING

    Tupelo, Mississippi, 38801, United States

  • Cooper University Hospital

    RECRUITING

    Camden, New Jersey, 08103, United States

  • Duke Univ Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Intermountain Medical Center

    RECRUITING

    Murray, Utah, 84107, United States

  • Novartis Investigative Site

    RECRUITING

    Calgary, Alberta, T2P 3C5, Canada

  • Novartis Investigative Site

    RECRUITING

    Vancouver, British Columbia, V5Z 1M9, Canada

  • Novartis Investigative Site

    RECRUITING

    Halifax, Nova Scotia, B3H 3A7, Canada

  • Novartis Investigative Site

    RECRUITING

    Hamilton, Ontario, L8L 2X2, Canada

  • Novartis Investigative Site

    RECRUITING

    London, Ontario, N6A 5W9, Canada

  • Novartis Investigative Site

    RECRUITING

    Newmarket, Ontario, L3Y 2P6, Canada

  • Novartis Investigative Site

    RECRUITING

    Toronto, Ontario, M4N 3M5, Canada

  • Novartis Investigative Site

    RECRUITING

    Toronto, Ontario, M5B 1W8, Canada

  • Novartis Investigative Site

    RECRUITING

    Montreal, Quebec, H1T 1C8, Canada

  • Novartis Investigative Site

    RECRUITING

    Montreal, Quebec, H2X 1R9, Canada

  • Novartis Investigative Site

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • Novartis Investigative Site

    RECRUITING

    Québec, Quebec, G1V 4G5, Canada

  • Novartis Investigative Site

    RECRUITING

    Sherbrooke, Quebec, J1H 5N4, Canada

  • Novartis Investigative Site

    RECRUITING

    Beijing, Beijing Municipality, 100013, China

  • Novartis Investigative Site

    RECRUITING

    Beijing, 100730, China

  • Novartis Investigative Site

    RECRUITING

    Xi'an, 223001, China

  • Novartis Investigative Site

    RECRUITING

    Bad Homburg, 61348, Germany

  • Novartis Investigative Site

    RECRUITING

    Berlin, 10787, Germany

  • Novartis Investigative Site

    RECRUITING

    Berlin, 13353, Germany

  • Novartis Investigative Site

    RECRUITING

    Hamburg, 20099, Germany

  • Novartis Investigative Site

    RECRUITING

    Hamburg, 20246, Germany

  • Novartis Investigative Site

    RECRUITING

    Arnhem, Gelderland, 6815 AD, Netherlands

  • Novartis Investigative Site

    RECRUITING

    Maastricht, Limburg, 6229 HX, Netherlands

  • Novartis Investigative Site

    RECRUITING

    Delft, South Holland, 2625 AD, Netherlands

  • Novartis Investigative Site

    RECRUITING

    Goes, Zeeland, 4462 RA, Netherlands

  • Novartis Investigative Site

    RECRUITING

    Groningen, 9713 GZ, Netherlands

  • Novartis Investigative Site

    RECRUITING

    Veldhoven, 5504 DB, Netherlands

  • Novartis Investigative Site

    RECRUITING

    Singapore, Singapore, S308433, Singapore

  • Novartis Investigative Site

    RECRUITING

    Singapore, 119074, Singapore

  • Novartis Investigative Site

    RECRUITING

    Singapore, 169609, Singapore

  • Novartis Investigative Site

    RECRUITING

    Brighton, East Sussex, BN2 5BE, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    Newcastle upon Tyne, Tyne and Wear, NE7 7DN, United Kingdom

  • Novartis Investigative Site

    WITHDRAWN

    Liverpool, L14 3PE, United Kingdom

  • Novartis Investigative Site

    RECRUITING

    London, W12 0HS, United Kingdom

  • Swedish Heart and Vascular Clinic

    RECRUITING

    Seattle, Washington, 98122, United States

  • Weill Cornell Medical Center

    RECRUITING

    New York, New York, 10021, United States

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