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Atrial fibrillation

A study to test how well BAY 3670549 works and how safe it is in patients with atrial fibrillation

Trial purpose

The main goal of this study is to find out how well BAY 3670549 works, how safe it is, how well people can tolerate it, and how the body handles the medicine. The study will compare BAY 3670549 to a placebo (a dummy treatment with no active medicine) in people with AF who need a treatment called electrical cardioversion.
Electrical cardioversion is a procedure that helps the heart return to a normal rhythm. In this study, each participant will get a single intravenous (IV) infusion of either BAY 3670549 or a placebo. Participants will then be observed to see whether the heart rhythm returns to a normal rhythm. If it does not, electrical cardioversion can still be performed as planned. The study will look at how many participants return from AF to a normal rhythm, without needing electrical cardioversion and how long it takes. It will also show how many participants experience medical problems after treatment and how BAY 3670549 move into, through and out of the participants’ body.
The total duration of the study for an individual participant may be up two months.
The findings from this study may contribute to the development of a new treatment option for people with AF.

Key Participants Requirements

Sex

All

Age

18 - 85 Years

Trial summary

Enrollment Goal
360
Trial Dates
June 2026 - May 2030
Phase
Phase II
Could I Receive a placebo
Yes
Products
BAY 3670549
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Not Yet Recruiting
Medizinische Hochschule Hannover|Kardiologie und AngiologieHannover, 30625, Germany
Not Yet Recruiting
Herz-und Diabeteszentrum NRW|Elektrophysiologie/RhythmologieBad Oeynhausen, 32545, Germany
Not Yet Recruiting
Klinikum Altenburger Land GmbH-Klinik für Kardiologie, Pneumologie und Internistische IntensivmedizinAltenburg, 04600, Germany
Not Yet Recruiting
CHRISTUS Trinity | Mother Frances Louis and Peaches Owen Heart Hospital - Electrophysiology ClinicTyler, 75701, United States
Not Yet Recruiting
Massachusetts General Hospital - CardiologyBoston, 02114, United States
Not Yet Recruiting
Duke University Hospital - CardiologyDurham, 27704, United States
Not Yet Recruiting
UCSF Advanced Heart Failure Comprehensive Care CenterSan Francisco, 94143, United States
Not Yet Recruiting
UCHealth University of Colorado Hospital - CardiologyAurora, 80045, United States
Not Yet Recruiting
Henry Ford Hospital - CardiologyDetroit, 48202, United States
Not Yet Recruiting
American Heart of Poland S.A. - MCSN, PAKS w Chrzanowie - Oddział Intensywnej Opieki KardiologicznejChrzanow, 32-500, Poland
Not Yet Recruiting
American Heart of Poland S.A. - PAKS Centrum Kardiologii i Kardiochirurgii w Bielsku-Białej - Oddział KardiologiiBielsko-Biała, 43-316, Poland
Not Yet Recruiting
USK nr 4 w Lublinie - Kliniczny Odd. Kardiologii, Reh. Kardio., Ch. Wew. z Pododdzialem Intensywnej Opieki Kardio.Lublin, 20-090, Poland
Not Yet Recruiting
Samodzielny Publiczny Specjalistyczny Szpital Zachodni im. sw. Jana Pawla IIGrodzisk Mazowiecki, 05 825, Poland
Not Yet Recruiting
Azienda Ospedaliero Universitaria Delle Marche - Clinica di Cardiologia e AritmologiaTorrette, 60126, Italy
Not Yet Recruiting
Centro Cardiologico Monzino S.p.A. - UO Scompenso e Cardiologia ClinicaMilano, 20138, Italy
Not Yet Recruiting
Azienda Ospedaliero-Universitaria Policlinico Umberto I - Malattie CardiovascolariRoma, 00161, Italy
Not Yet Recruiting
Ente Ecclesiastico Ospedale Generale Regionale Miulli - Cardiologia e UTICAcquaviva delle Fonti, 70021, Italy
Not Yet Recruiting
Jessa Ziekenhuis | Hartcentrum HasseltHasselt, 3500, Belgium
Not Yet Recruiting
UZ Leuven Gasthuisberg - Cardiology diseases departmentLeuven, 3000, Belgium
Not Yet Recruiting
AZ Delta | Clinical Trial Center - CardiologyRoeselare, 8800, Belgium
Not Yet Recruiting
Universitair Medisch Centrum GroningenGroningen, 9713 GZ, Netherlands
Not Yet Recruiting
Maastricht UMCMaastricht, 6229 HX, Netherlands
Not Yet Recruiting
Multiprofile Hospital for Active Treatment Dr. Stefan Cherkezov | Base 1 - Cardiology DepartmentVeliko Tarnovo, 5000, Bulgaria
Not Yet Recruiting
Multiprofile Hospital for Active Treatment Knyaginya Klementina Sofia EAD | Cardiology DepartmentSofia, 1233, Bulgaria
Not Yet Recruiting
University Hospital for Active Treatment Tsaritsa Joanna - ISUL | Cardiology ClinicSofia, 1527, Bulgaria
Not Yet Recruiting
University Multiprofile Hospital For Active Treatment Sveti Georgi' - EAD Department of Intensive Cardiology"Plovdiv, 4001, Bulgaria
Not Yet Recruiting
Semmelweis Egyetem, Varosmajori Sziv- és Ergyogyaszati KlinikaBudapest, 1122, Hungary
Not Yet Recruiting
Tolna Vármegyei Balassa János Kórház - I. Belgyógyászati Osztály: Kardiológia, NefrológiaSzekszárd, 7100, Hungary

Primary Outcome

  • Number of Participants with conversion from atrial fibrillation (AF) to sinus rhythm (SR), sustained for ≥1 minute, within 3 hours after start of study intervention administration, and prior to use of rescue therapy or other SoC for cardioversion
    AF = atrial fibrillation ; SR = sinus rhythm ; SoC = Standard of Care ; *Pre-dose: Within 4 h prior to study intervention administration
    date_rangeTime Frame:
    From pre-dose* up to 3 hours after start of administration of study intervention

Secondary Outcome

  • Number of Participants who experienced Treatment Emergent Adverse Events (TEAE)s
    TEAE = Treatment Emergent Adverse Events; *Pre-dose: Within 4 h prior to study intervention administration
    date_rangeTime Frame:
    From pre-dose* up to 48 h after start of administration of study intervention
  • Time to conversion from AF to SR as defined in the primary endpoint
    AF = atrial fibrillation SR = sinus rhythm ; *Pre-dose: Within 4 h prior to study intervention administration
    date_rangeTime Frame:
    From pre-dose* up to 3 hours after start of administration of study intervention
  • Number of Participants in SR, at 3 hours after start of study intervention administration without prior use of rescue therapy or other SoC for cardioversion
    SoC = Standard of Care: *Pre-dose: Within 4 h prior to study intervention administration
    date_rangeTime Frame:
    From pre-dose* up to 3 hours after start of administration of study intervention
  • Plasma concentration of BAY 3670549 at the end of the infusion
    *Pre-dose: Within 4 h prior to study intervention administration
    date_rangeTime Frame:
    From pre-dose* up to 8 h after start of administration of study intervention

Trial design

A placebo-controlled, parallel-group, double blind, randomized, multi-cohort Phase 2 study to investigate efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics of BAY 3670549 in adult participants with atrial fibrillation.
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double-blind
Assignment
Parallel
Trial Arms
2