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

2026年10月19日 更新者：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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

360

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 保加利亚
    • Plovdiv Province
      • Plovdiv、Plovdiv Province、保加利亚、4001
        • 尚未招聘
        • University Multiprofile Hospital For Active Treatment Sveti Georgi' - EAD Department of Intensive Cardiology"
    • Sofia City Province
      • Sofia、Sofia City Province、保加利亚、1233
        • 尚未招聘
        • Multiprofile Hospital for Active Treatment Knyaginya Klementina Sofia EAD | Cardiology Department
      • Sofia、Sofia City Province、保加利亚、1527
        • 招聘中
        • University Hospital for Active Treatment Tsaritsa Joanna - ISUL | Cardiology Clinic
    • Veliko Tarnovo Province
      • Veliko Tarnovo、Veliko Tarnovo Province、保加利亚、5000
        • 招聘中
        • Multiprofile Hospital for Active Treatment Dr. Stefan Cherkezov | Base 1 - Cardiology Department
  • 匈牙利
      • Budapest、匈牙利、1122
        • 招聘中
        • Semmelweis Egyetem, Varosmajori Sziv- és Ergyogyaszati Klinika
    • Tolna County
      • Szekszárd、Tolna County、匈牙利、7100
        • 尚未招聘
        • Tolna Vármegyei Balassa János Kórház - I. Belgyógyászati Osztály: Kardiológia, Nefrológia
  • 德国
    • Lower Saxony
      • Hanover、Lower Saxony、德国、30625
        • 尚未招聘
        • Medizinische Hochschule Hannover|Kardiologie und Angiologie
    • North Rhine-Westphalia
      • Bad Oeynhausen、North Rhine-Westphalia、德国、32545
        • 尚未招聘
        • Herz-und Diabeteszentrum NRW|Elektrophysiologie/Rhythmologie
    • Thuringia
      • Altenburg、Thuringia、德国、04600
        • 招聘中
        • Klinikum Altenburger Land GmbH-Klinik für Kardiologie, Pneumologie und Internistische Intensivmedizin
  • 意大利
    • Apulia
      • Acquaviva delle Fonti、Apulia、意大利、70021
        • 招聘中
        • Ente Ecclesiastico Ospedale Generale Regionale Miulli - Cardiologia e UTIC
    • Lazio
      • Rome、Lazio、意大利、00161
        • 尚未招聘
        • Azienda Ospedaliero-Universitaria Policlinico Umberto I - Malattie Cardiovascolari
    • Lombardy
      • Milan、Lombardy、意大利、20138
        • 招聘中
        • Centro Cardiologico Monzino S.p.A. - UO Scompenso e Cardiologia Clinica
    • The Marches
      • Torrette、The Marches、意大利、60126
        • 尚未招聘
        • Azienda Ospedaliero Universitaria Delle Marche - Clinica di Cardiologia e Aritmologia
  • 比利时
    • Flemish Brabant
      • Leuven、Flemish Brabant、比利时、3000
        • 招聘中
        • UZ Leuven Gasthuisberg - Cardiology diseases department
    • Limburg
      • Hasselt、Limburg、比利时、3500
        • 尚未招聘
        • Jessa Ziekenhuis | Hartcentrum Hasselt
    • West Flanders
      • Roeselare、West Flanders、比利时、8800
        • 尚未招聘
        • AZ Delta | Clinical Trial Center - Cardiology
  • 波兰
    • Lesser Poland Voivodeship
      • Chrzanów、Lesser Poland Voivodeship、波兰、32-500
        • 尚未招聘
        • American Heart of Poland S.A. - MCSN, PAKS w Chrzanowie - Oddział Intensywnej Opieki Kardiologicznej
    • Lublin Voivodeship
      • Lublin、Lublin Voivodeship、波兰、20-090
        • 尚未招聘
        • USK nr 4 w Lublinie - Kliniczny Odd. Kardiologii, Reh. Kardio., Ch. Wew. z Pododdzialem Intensywnej Opieki Kardio.
    • Masovian Voivodeship
      • Grodzisk Mazowiecki、Masovian Voivodeship、波兰、05-825
        • 招聘中
        • Samodzielny Publiczny Specjalistyczny Szpital Zachodni im. sw. Jana Pawla II
    • Silesian Voivodeship
      • Bielsko-Biala、Silesian Voivodeship、波兰、43-316
        • 尚未招聘
        • American Heart of Poland S.A. - PAKS Centrum Kardiologii i Kardiochirurgii w Bielsku-Białej - Oddział Kardiologii
  • 美国
    • California
      • San Francisco、California、美国、94143
        • 撤销
        • UCSF Advanced Heart Failure Comprehensive Care Center
    • Colorado
      • Aurora、Colorado、美国、80045
        • 尚未招聘
        • UCHealth University of Colorado Hospital - Cardiology
    • Massachusetts
      • Boston、Massachusetts、美国、02114
        • 尚未招聘
        • Massachusetts General Hospital - Cardiology
    • Michigan
      • Detroit、Michigan、美国、48202
        • 招聘中
        • Henry Ford Hospital - Cardiology
    • Minnesota
      • Maplewood、Minnesota、美国、55109
        • 撤销
        • M Health Fairview Heart Clinic - Maplewood
    • North Carolina
      • Durham、North Carolina、美国、27704
        • 尚未招聘
        • Duke University Hospital - Cardiology
    • Texas
      • Fort Worth、Texas、美国、76104
        • 尚未招聘
        • Texas Health Heart and Vascular Specialists - Fort Worth
      • Tyler、Texas、美国、75701
        • 尚未招聘
        • CHRISTUS Trinity | Mother Frances Louis and Peaches Owen Heart Hospital - Electrophysiology Clinic
  • 荷兰
      • Groningen、荷兰、9713 GZ
        • 尚未招聘
        • Universitair Medisch Centrum Groningen
    • Limburg
      • Maastricht、Limburg、荷兰、6229 HX
        • 尚未招聘
        • Maastricht UMC

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 85年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：安慰剂
其他：Placebo

intravenous (IV) treatment
实验性的：BAY 3670549
药品：BAY 3670549

intravenous (IV) treatment

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
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
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Number of Participants who experienced Treatment Emergent Adverse Events (TEAE)s
大体时间：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
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Bayer

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年9月1日

初级完成 (估计的)

2030年5月16日

研究完成 (估计的)

2030年5月16日

研究注册日期

首次提交

2026年5月13日

首先提交符合 QC 标准的

2026年6月1日

首次发布 (实际的)

2026年6月4日

研究记录更新

最后更新发布 (实际的)

2026年10月20日

上次提交的符合 QC 标准的更新

2026年10月19日

最后验证

2026年10月6日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 22961
  • 2025-523807-31-00 (克蒂斯)
  • 2025 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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