A Study to Test How Well BAY 3670549 Works and How Safe it is in Patients With Atrial Fibrillation (CARDIOVERT)
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 2
Contactos e Locais
Contato de estudo
- Nome: Bayer Clinical Trials Contact
- Número de telefone: 18888422937
- E-mail: clinical-trials-contact@bayer.com
Locais de estudo
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Lower Saxony
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Hanover, Lower Saxony, Alemanha, 30625
- Ainda não está recrutando
- Medizinische Hochschule Hannover|Kardiologie und Angiologie
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North Rhine-Westphalia
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Bad Oeynhausen, North Rhine-Westphalia, Alemanha, 32545
- Ainda não está recrutando
- Herz-und Diabeteszentrum NRW|Elektrophysiologie/Rhythmologie
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Thuringia
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Altenburg, Thuringia, Alemanha, 04600
- Recrutamento
- Klinikum Altenburger Land GmbH-Klinik für Kardiologie, Pneumologie und Internistische Intensivmedizin
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Plovdiv Province
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Plovdiv, Plovdiv Province, Bulgária, 4001
- Ainda não está recrutando
- 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, Bulgária, 1233
- Ainda não está recrutando
- Multiprofile Hospital for Active Treatment Knyaginya Klementina Sofia EAD | Cardiology Department
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Sofia, Sofia City Province, Bulgária, 1527
- Recrutamento
- 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, Bulgária, 5000
- Recrutamento
- Multiprofile Hospital for Active Treatment Dr. Stefan Cherkezov | Base 1 - Cardiology Department
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Flemish Brabant
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Leuven, Flemish Brabant, Bélgica, 3000
- Recrutamento
- UZ Leuven Gasthuisberg - Cardiology diseases department
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Limburg
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Hasselt, Limburg, Bélgica, 3500
- Ainda não está recrutando
- Jessa Ziekenhuis | Hartcentrum Hasselt
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West Flanders
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Roeselare, West Flanders, Bélgica, 8800
- Ainda não está recrutando
- AZ Delta | Clinical Trial Center - Cardiology
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California
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San Francisco, California, Estados Unidos, 94143
- Retirado
- UCSF Advanced Heart Failure Comprehensive Care Center
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Colorado
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Aurora, Colorado, Estados Unidos, 80045
- Ainda não está recrutando
- UCHealth University of Colorado Hospital - Cardiology
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02114
- Ainda não está recrutando
- Massachusetts General Hospital - Cardiology
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Michigan
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Detroit, Michigan, Estados Unidos, 48202
- Recrutamento
- Henry Ford Hospital - Cardiology
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Minnesota
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Maplewood, Minnesota, Estados Unidos, 55109
- Retirado
- M Health Fairview Heart Clinic - Maplewood
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North Carolina
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Durham, North Carolina, Estados Unidos, 27704
- Ainda não está recrutando
- Duke University Hospital - Cardiology
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Texas
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Fort Worth, Texas, Estados Unidos, 76104
- Ainda não está recrutando
- Texas Health Heart and Vascular Specialists - Fort Worth
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Tyler, Texas, Estados Unidos, 75701
- Ainda não está recrutando
- CHRISTUS Trinity | Mother Frances Louis and Peaches Owen Heart Hospital - Electrophysiology Clinic
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Groningen, Holanda, 9713 GZ
- Ainda não está recrutando
- Universitair Medisch Centrum Groningen
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Limburg
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Maastricht, Limburg, Holanda, 6229 HX
- Ainda não está recrutando
- Maastricht UMC
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Budapest, Hungria, 1122
- Recrutamento
- Semmelweis Egyetem, Varosmajori Sziv- és Ergyogyaszati Klinika
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Tolna County
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Szekszárd, Tolna County, Hungria, 7100
- Ainda não está recrutando
- Tolna Vármegyei Balassa János Kórház - I. Belgyógyászati Osztály: Kardiológia, Nefrológia
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Apulia
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Acquaviva delle Fonti, Apulia, Itália, 70021
- Recrutamento
- Ente Ecclesiastico Ospedale Generale Regionale Miulli - Cardiologia e UTIC
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Lazio
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Rome, Lazio, Itália, 00161
- Ainda não está recrutando
- Azienda Ospedaliero-Universitaria Policlinico Umberto I - Malattie Cardiovascolari
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Lombardy
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Milan, Lombardy, Itália, 20138
- Recrutamento
- Centro Cardiologico Monzino S.p.A. - UO Scompenso e Cardiologia Clinica
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The Marches
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Torrette, The Marches, Itália, 60126
- Ainda não está recrutando
- Azienda Ospedaliero Universitaria Delle Marche - Clinica di Cardiologia e Aritmologia
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Lesser Poland Voivodeship
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Chrzanów, Lesser Poland Voivodeship, Polônia, 32-500
- Ainda não está recrutando
- American Heart of Poland S.A. - MCSN, PAKS w Chrzanowie - Oddział Intensywnej Opieki Kardiologicznej
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Lublin Voivodeship
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Lublin, Lublin Voivodeship, Polônia, 20-090
- Ainda não está recrutando
- USK nr 4 w Lublinie - Kliniczny Odd. Kardiologii, Reh. Kardio., Ch. Wew. z Pododdzialem Intensywnej Opieki Kardio.
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Masovian Voivodeship
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Grodzisk Mazowiecki, Masovian Voivodeship, Polônia, 05-825
- Recrutamento
- Samodzielny Publiczny Specjalistyczny Szpital Zachodni im. sw. Jana Pawla II
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Silesian Voivodeship
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Bielsko-Biala, Silesian Voivodeship, Polônia, 43-316
- Ainda não está recrutando
- American Heart of Poland S.A. - PAKS Centrum Kardiologii i Kardiochirurgii w Bielsku-Białej - Oddział Kardiologii
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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:
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Current atrial flutter (AFL) or combined AF/AFL
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Contraindication for electrical cardioversion on planned treatment day
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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
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Unsuccessful conversion of current AF episode (pharmacologically or electrically)
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Known severe valvular heart disease (e.g., severe mitral regurgitation, severe aortic stenosis)
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Patients with NYHA Class ≥ III heart failure, or with active management of acute heart failure decompensation on treatment day.
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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
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Severe renal impairment, i.e., estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m² (using CKD-EPI formula) or requiring dialysis
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Severe hepatic impairment, i.e. Child Pugh Class C
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Use of anti-arrhythmic class I or III drugs within 5 half-lives before study drug administration (oral amiodarone in the previous 3 months)
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Hypertension with SBP ≥ 180 mmHg or hypotension (SBP < 90 mmHg) at randomization (based on the second BP measurement)
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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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador de Placebo: Placebo
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intravenous (IV) treatment |
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Experimental: BAY 3670549
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intravenous (IV) treatment |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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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
Prazo: 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; |
Up to 3 hours after start of administration of study intervention
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of Participants who experienced Treatment Emergent Adverse Events (TEAE)s
Prazo: 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 |
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
Prazo: Up to 3 hours after start of administration of study intervention
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AF = atrial fibrillation SR = sinus rhythm; |
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
Prazo: Up to 3 hours after start of administration of study intervention
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SoC = Standard of Care; |
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
Prazo: 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 |
From pre-dose* up to 8 hours after start of administration of study intervention
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 22961
- 2025-523807-31-00 (Ctis)
- 2025 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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.
Informações sobre medicamentos e dispositivos, documentos de estudo
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