A Study to Test How Well BAY 3670549 Works and How Safe it is in Patients With Atrial Fibrillation (CARDIOVERT)
8. september 2026 oppdatert av: Bayer
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.
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.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
360
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Bayer Clinical Trials Contact
- Telefonnummer: 18888422937
- E-post: clinical-trials-contact@bayer.com
Studiesteder
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Flemish Brabant
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Leuven, Flemish Brabant, Belgia, 3000
- Har ikke rekruttert ennå
- UZ Leuven Gasthuisberg - Cardiology diseases department
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Limburg
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Hasselt, Limburg, Belgia, 3500
- Har ikke rekruttert ennå
- Jessa Ziekenhuis | Hartcentrum Hasselt
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West Flanders
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Roeselare, West Flanders, Belgia, 8800
- Har ikke rekruttert ennå
- AZ Delta | Clinical Trial Center - Cardiology
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Plovdiv Province
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Plovdiv, Plovdiv Province, Bulgaria, 4001
- Har ikke rekruttert ennå
- University Multiprofile Hospital For Active Treatment Sveti Georgi' - EAD Department of Intensive Cardiology"
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Sofia City Province
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Sofia, Sofia City Province, Bulgaria, 1233
- Har ikke rekruttert ennå
- Multiprofile Hospital for Active Treatment Knyaginya Klementina Sofia EAD | Cardiology Department
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Sofia, Sofia City Province, Bulgaria, 1527
- Har ikke rekruttert ennå
- University Hospital for Active Treatment Tsaritsa Joanna - ISUL | Cardiology Clinic
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Veliko Tarnovo Province
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Veliko Tarnovo, Veliko Tarnovo Province, Bulgaria, 5000
- Har ikke rekruttert ennå
- Multiprofile Hospital for Active Treatment Dr. Stefan Cherkezov | Base 1 - Cardiology Department
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California
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San Francisco, California, Forente stater, 94143
- Tilbaketrukket
- UCSF Advanced Heart Failure Comprehensive Care Center
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Colorado
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Aurora, Colorado, Forente stater, 80045
- Har ikke rekruttert ennå
- UCHealth University of Colorado Hospital - Cardiology
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Massachusetts
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Boston, Massachusetts, Forente stater, 02114
- Har ikke rekruttert ennå
- Massachusetts General Hospital - Cardiology
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Michigan
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Detroit, Michigan, Forente stater, 48202
- Har ikke rekruttert ennå
- Henry Ford Hospital - Cardiology
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North Carolina
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Durham, North Carolina, Forente stater, 27704
- Har ikke rekruttert ennå
- Duke University Hospital - Cardiology
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Texas
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Fort Worth, Texas, Forente stater, 76104
- Har ikke rekruttert ennå
- Texas Health Heart and Vascular Specialists - Fort Worth
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Tyler, Texas, Forente stater, 75701
- Tilbaketrukket
- CHRISTUS Trinity | Mother Frances Louis and Peaches Owen Heart Hospital - Electrophysiology Clinic
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Acquaviva delle Fonti, Italia, 70021
- Har ikke rekruttert ennå
- Ente Ecclesiastico Ospedale Generale Regionale Miulli - Cardiologia e UTIC
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Milan, Italia, 20138
- Rekruttering
- Centro Cardiologico Monzino S.p.A. - UO Scompenso e Cardiologia Clinica
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Roma, Italia, 00161
- Har ikke rekruttert ennå
- Azienda Ospedaliero-Universitaria Policlinico Umberto I - Malattie Cardiovascolari
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Torrette, Italia, 60126
- Har ikke rekruttert ennå
- Azienda Ospedaliero Universitaria Delle Marche - Clinica di Cardiologia e Aritmologia
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Groningen, Nederland, 9713 GZ
- Har ikke rekruttert ennå
- Universitair Medisch Centrum Groningen
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Limburg
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Maastricht, Limburg, Nederland, 6229 HX
- Har ikke rekruttert ennå
- Maastricht UMC
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Bielsko-Biala, Polen, 43-316
- Har ikke rekruttert ennå
- American Heart of Poland S.A. - PAKS Centrum Kardiologii i Kardiochirurgii w Bielsku-Białej - Oddział Kardiologii
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Chrzanów, Polen, 32-500
- Har ikke rekruttert ennå
- American Heart of Poland S.A. - MCSN, PAKS w Chrzanowie - Oddział Intensywnej Opieki Kardiologicznej
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Grodzisk Mazowiecki, Polen, 05-825
- Har ikke rekruttert ennå
- Samodzielny Publiczny Specjalistyczny Szpital Zachodni im. sw. Jana Pawla II
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Lublin, Polen, 20-090
- Har ikke rekruttert ennå
- USK nr 4 w Lublinie - Kliniczny Odd. Kardiologii, Reh. Kardio., Ch. Wew. z Pododdzialem Intensywnej Opieki Kardio.
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Lower Saxony
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Hanover, Lower Saxony, Tyskland, 30625
- Har ikke rekruttert ennå
- Medizinische Hochschule Hannover|Kardiologie und Angiologie
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North Rhine-Westphalia
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Bad Oeynhausen, North Rhine-Westphalia, Tyskland, 32545
- Har ikke rekruttert ennå
- Herz-und Diabeteszentrum NRW|Elektrophysiologie/Rhythmologie
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Thuringia
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Altenburg, Thuringia, Tyskland, 04600
- Har ikke rekruttert ennå
- Klinikum Altenburger Land GmbH-Klinik für Kardiologie, Pneumologie und Internistische Intensivmedizin
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Budapest, Ungarn, 1122
- Har ikke rekruttert ennå
- Semmelweis Egyetem, Varosmajori Sziv- es Ergyogyaszati Klinika
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Tolna County
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Szekszárd, Tolna County, Ungarn, 7100
- Har ikke rekruttert ennå
- Tolna Vármegyei Balassa János Kórház - I. Belgyógyászati Osztály: Kardiológia, Nefrológia
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Participant must be 18 to 85 years of age inclusive, at the time of signing the informed consent.
- Participant is hemodynamically stable and does not require emergency cardioversion, as determined by the investigator.
- Participant has a current episode of atrial fibrillation (AF) ongoing for at least 3 hours and no more than 30 days at the time of randomization.
- Participant has an indication for electrical cardioversion of AF, as determined by the investigator according to standard clinical practice and national/institutional guidelines.
- At randomization, successful initiation and achievement of therapeutic levels of anticoagulation therapy, as well as completion of imaging evaluation for left atrial thrombi, as appropriate for the duration of the AF episode and risk for the participant according to national guideline and institution-specific routine practice.
- BMI within range [18 - 39.9] kg/m2.
- Contraceptive use by participants or participant partners should be consistent with the study protocol and local regulations regarding the methods of contraception for those participating in clinical studies.
- Signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
- Willing and able to comply with the receipt, home use, and return of the continuous ECG recording device, as well as with the participation in scheduled telephone follow-up assessments.
Exclusion Criteria:
- Current atrial flutter (AFL) or combined AF/AFL
- Contraindication for electrical cardioversion on planned treatment day
- Documented severely dilated left atrium (left atrial diameter, LAD >5 cm) measured by any modality within the 6 months prior to screening; if several values are available, the most recent one shall be reported. If left atrium diameter was not measured in the last 6 months or a major cardiovascular event occurred within the last 6 months, a new measurement must be done at screening
- Unsuccessful conversion of current AF episode (pharmacologically or electrically)
- Known severe valvular heart disease (e.g., severe mitral regurgitation, severe aortic stenosis)
- Patients with NYHA Class ≥ III heart failure, or with active management of acute heart failure decompensation on treatment day.
History within the preceding 3 months prior to randomization of any of the following events, or any other significant cardiovascular event as judged by the investigator:
- Stroke
- Myocardial infarction
- Unstable angina pectoris or other signs of myocardial ischemia
- Cardiac surgery
- Transcatheter valve replacement
- Percutaneous coronary intervention (PCI)
- Coronary artery bypass graft (CABG) or other revascularization procedure
- Severe renal impairment, i.e., estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m² (using CKD-EPI formula) or requiring dialysis
- Severe hepatic impairment, i.e. Child Pugh Class C
- Use of anti-arrhythmic class I or III drugs within 5 half-lives before study drug administration (oral amiodarone in the previous 3 months)
- Hypertension with SBP ≥ 180 mmHg or hypotension (SBP < 90 mmHg) at randomization (based on the second BP measurement)
- Stressor-associated AF, i.e., in the setting of an acute and reversible stressor (e.g., cardiac surgery, myocarditis, endocarditis, sepsis, pneumonia, etc.). This includes ablation procedure within the preceding one month prior to randomization.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Placebo komparator: Placebo
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intravenous (IV) treatment
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Eksperimentell: BAY 3670549
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intravenous (IV) treatment
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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
Tidsramme: Up to 3 hours after start of administration of study intervention
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AF = atrial fibrillation ; SR = sinus rhythm ; SoC = Standard of Care;
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Up to 3 hours after start of administration of study intervention
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants who experienced Treatment Emergent Adverse Events (TEAE)s
Tidsramme: From pre-dose* up to 48 hours after start of administration of study intervention
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TEAE = Treatment Emergent Adverse Events; *Pre-dose: Within 4 hours prior to study intervention administration
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From pre-dose* up to 48 hours after start of administration of study intervention
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Time to conversion from AF to SR as defined in the primary endpoint
Tidsramme: Up to 3 hours after start of administration of study intervention
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AF = atrial fibrillation SR = sinus rhythm;
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Up to 3 hours after start of administration of study intervention
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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
Tidsramme: Up to 3 hours after start of administration of study intervention
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SoC = Standard of Care;
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Up to 3 hours after start of administration of study intervention
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Plasma concentration of BAY 3670549 at the end of the infusion
Tidsramme: From pre-dose* up to 8 hours after start of administration of study intervention
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*Pre-dose: Within 4 hours prior to study intervention administration
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From pre-dose* up to 8 hours after start of administration of study intervention
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
18. august 2026
Primær fullføring (Antatt)
16. mai 2030
Studiet fullført (Antatt)
16. mai 2030
Datoer for studieregistrering
Først innsendt
13. mai 2026
Først innsendt som oppfylte QC-kriteriene
1. juni 2026
Først lagt ut (Faktiske)
4. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. september 2026
Sist bekreftet
29. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 22961
- 2025 (U.S. NIH-stipend/kontrakt: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- 2025-523807-31-00 (Ctis)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing".
This pertains to scope, timepoint and process of data access.
As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research.
This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research.
Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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