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Clinical Trials in the UK / NCT07217067
Recruiting Phase 2

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

NCT07217067 · tracked via the Priya Life Science UK tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 2
Started
2025-10-28
Last updated
2026-07-31

Condition(s) studied

Atrial Fibrillation

Investigational drug(s) / intervention(s)

PKN605Placebo

PKN605: PKN605 is an oral formulation

Placebo: Matching placebo

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (40)

FacilityCityRegionStatus
Cardiology Associates of North MS Tupelo Mississippi Recruiting
Cooper University Hospital Camden New Jersey Recruiting
Weill Cornell Medical Center New York New York Recruiting
Duke Univ Medical Center Durham North Carolina Recruiting
Intermountain Medical Center Murray Utah Recruiting
Swedish Heart and Vascular Clinic Seattle Washington Recruiting
Novartis Investigative Site Calgary Alberta Recruiting
Novartis Investigative Site Vancouver British Columbia Recruiting
Novartis Investigative Site Halifax Nova Scotia Recruiting
Novartis Investigative Site Hamilton Ontario Recruiting
Novartis Investigative Site London Ontario Recruiting
Novartis Investigative Site Newmarket Ontario Recruiting
Novartis Investigative Site Toronto Ontario Recruiting
Novartis Investigative Site Toronto Ontario Recruiting
Novartis Investigative Site Montreal Quebec Recruiting
Novartis Investigative Site Montreal Quebec Recruiting
Novartis Investigative Site Montreal Quebec Recruiting
Novartis Investigative Site Québec Quebec Recruiting
Novartis Investigative Site Sherbrooke Quebec Recruiting
Novartis Investigative Site Beijing Beijing Municipality Recruiting
Novartis Investigative Site Beijing China Recruiting
Novartis Investigative Site Xi'an China Recruiting
Novartis Investigative Site Bad Homburg Germany Recruiting
Novartis Investigative Site Berlin Germany Recruiting
Novartis Investigative Site Berlin Germany Recruiting
Novartis Investigative Site Hamburg Germany Recruiting
Novartis Investigative Site Hamburg Germany Recruiting
Novartis Investigative Site Arnhem Gelderland Recruiting
Novartis Investigative Site Maastricht Limburg Recruiting
Novartis Investigative Site Delft South Holland Recruiting
Novartis Investigative Site Goes Zeeland Recruiting
Novartis Investigative Site Groningen Netherlands Recruiting
Novartis Investigative Site Veldhoven Netherlands Recruiting
Novartis Investigative Site Singapore Singapore Recruiting
Novartis Investigative Site Singapore Singapore Recruiting
Novartis Investigative Site Singapore Singapore Recruiting
Novartis Investigative Site Brighton East Sussex Recruiting
Novartis Investigative Site Newcastle upon Tyne Tyne and Wear Recruiting
Novartis Investigative Site Liverpool United Kingdom Withdrawn
Novartis Investigative Site London United Kingdom Recruiting

More Novartis Pharmaceuticals trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07217067 on ClinicalTrials.gov ↗ ← All trials in the UK