Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

A Study to Test How Well BAY 3670549 Works and How Safe it is in Patients With Atrial Fibrillation (CARDIOVERT)

1. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

360

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Belgien
      • Hasselt, Belgien, 3500
        • Jessa Ziekenhuis | Hartcentrum Hasselt
      • Leuven, Belgien, 3000
        • UZ Leuven Gasthuisberg - Cardiology diseases department
      • Roeselare, Belgien, 8800
        • AZ Delta | Clinical Trial Center - Cardiology
  • Bulgarien
    • Plovdiv Province
      • Plovdiv, Plovdiv Province, Bulgarien, 4001
        • University Multiprofile Hospital For Active Treatment Sveti Georgi' - EAD Department of Intensive Cardiology"
    • Sofia City Province
      • Sofia, Sofia City Province, Bulgarien, 1233
        • Multiprofile Hospital for Active Treatment Knyaginya Klementina Sofia EAD | Cardiology Department
      • Sofia, Sofia City Province, Bulgarien, 1527
        • University Hospital for Active Treatment Tsaritsa Joanna - ISUL | Cardiology Clinic
    • Veliko Tarnovo Province
      • Veliko Tarnovo, Veliko Tarnovo Province, Bulgarien, 5000
        • Multiprofile Hospital for Active Treatment Dr. Stefan Cherkezov | Base 1 - Cardiology Department
  • Forenede Stater
    • California
      • San Francisco, California, Forenede Stater, 94143
        • UCSF Advanced Heart Failure Comprehensive Care Center
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • UCHealth University of Colorado Hospital - Cardiology
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02114
        • Massachusetts General Hospital - Cardiology
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48202
        • Henry Ford Hospital - Cardiology
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27704
        • Duke University Hospital - Cardiology
    • Texas
      • Tyler, Texas, Forenede Stater, 75701
        • CHRISTUS Trinity | Mother Frances Louis and Peaches Owen Heart Hospital - Electrophysiology Clinic
  • Holland
      • Groningen, Holland, 9713 GZ
        • Universitair Medisch Centrum Groningen
    • Limburg
      • Maastricht, Limburg, Holland, 6229 HX
        • Maastricht UMC
  • Italien
      • Acquaviva delle Fonti, Italien, 70021
        • Ente Ecclesiastico Ospedale Generale Regionale Miulli - Cardiologia e UTIC
      • Milan, Italien, 20138
        • Centro Cardiologico Monzino S.p.A. - UO Scompenso e Cardiologia Clinica
      • Roma, Italien, 00161
        • Azienda Ospedaliero-Universitaria Policlinico Umberto I - Malattie Cardiovascolari
      • Torrette, Italien, 60126
        • Azienda Ospedaliero Universitaria Delle Marche - Clinica di Cardiologia e Aritmologia
  • Polen
      • Bielsko-Biala, Polen, 43-316
        • American Heart of Poland S.A. - PAKS Centrum Kardiologii i Kardiochirurgii w Bielsku-Białej - Oddział Kardiologii
      • Chrzanów, Polen, 32-500
        • American Heart of Poland S.A. - MCSN, PAKS w Chrzanowie - Oddział Intensywnej Opieki Kardiologicznej
      • Grodzisk Mazowiecki, Polen, 05 825
        • Samodzielny Publiczny Specjalistyczny Szpital Zachodni im. sw. Jana Pawla II
      • Lublin, Polen, 20-090
        • USK nr 4 w Lublinie - Kliniczny Odd. Kardiologii, Reh. Kardio., Ch. Wew. z Pododdzialem Intensywnej Opieki Kardio.
  • Tyskland
      • Altenburg, Tyskland, 04600
        • Klinikum Altenburger Land GmbH-Klinik für Kardiologie, Pneumologie und Internistische Intensivmedizin
    • Lower Saxony
      • Hanover, Lower Saxony, Tyskland, 30625
        • Medizinische Hochschule Hannover|Kardiologie und Angiologie
    • North Rhine-Westphalia
      • Bad Oeynhausen, North Rhine-Westphalia, Tyskland, 32545
        • Herz-und Diabeteszentrum NRW|Elektrophysiologie/Rhythmologie
  • Ungarn
      • Budapest, Ungarn, 1122
        • Semmelweis Egyetem, Varosmajori Sziv- és Ergyogyaszati Klinika
      • Szekszárd, Ungarn, 7100
        • Tolna Vármegyei Balassa János Kórház - I. Belgyógyászati Osztály: Kardiológia, Nefrológia

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Andet: Placebo
intravenous (IV) treatment
Eksperimentel: BAY 3670549
Medicin: BAY 3670549
intravenous (IV) treatment

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
AF = atrial fibrillation ; SR = sinus rhythm ; SoC = Standard of Care;
Up to 3 hours after start of administration of study intervention

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
TEAE = Treatment Emergent Adverse Events; *Pre-dose: Within 4 hours prior to study intervention administration
From pre-dose* up to 48 hours after start of administration of study intervention
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
AF = atrial fibrillation SR = sinus rhythm;
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
Tidsramme: Up to 3 hours after start of administration of study intervention
SoC = Standard of Care;
Up to 3 hours after start of administration of study intervention
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
*Pre-dose: Within 4 hours prior to study intervention administration
From pre-dose* up to 8 hours after start of administration of study intervention

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Bayer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

19. juni 2026

Primær færdiggørelse (Anslået)

16. maj 2030

Studieafslutning (Anslået)

16. maj 2030

Datoer for studieregistrering

Først indsendt

13. maj 2026

Først indsendt, der opfyldte QC-kriterier

1. juni 2026

Først opslået (Faktiske)

4. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juni 2026

Sidst verificeret

18. februar 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 22961
  • 2025-523807-31-00 (Ctis)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Atrieflimren

Kliniske forsøg med BAY 3670549

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Lithuania

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner