A Study to Test How Well BAY 3670549 Works and How Safe it is in Patients With Atrial Fibrillation (CARDIOVERT)
2026년 9월 8일 업데이트: 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.
연구 개요
연구 유형
중재적
등록 (추정된)
360
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Bayer Clinical Trials Contact
- 전화번호: 18888422937
- 이메일: clinical-trials-contact@bayer.com
연구 장소
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Groningen, 네덜란드, 9713 GZ
- 아직 모집하지 않음
- Universitair Medisch Centrum Groningen
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Limburg
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Maastricht, Limburg, 네덜란드, 6229 HX
- 아직 모집하지 않음
- Maastricht UMC
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Lower Saxony
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Hanover, Lower Saxony, 독일, 30625
- 아직 모집하지 않음
- Medizinische Hochschule Hannover|Kardiologie und Angiologie
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North Rhine-Westphalia
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Bad Oeynhausen, North Rhine-Westphalia, 독일, 32545
- 아직 모집하지 않음
- Herz-und Diabeteszentrum NRW|Elektrophysiologie/Rhythmologie
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Thuringia
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Altenburg, Thuringia, 독일, 04600
- 아직 모집하지 않음
- Klinikum Altenburger Land GmbH-Klinik für Kardiologie, Pneumologie und Internistische Intensivmedizin
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California
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San Francisco, California, 미국, 94143
- 빼는
- UCSF Advanced Heart Failure Comprehensive Care Center
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Colorado
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Aurora, Colorado, 미국, 80045
- 아직 모집하지 않음
- UCHealth University of Colorado Hospital - Cardiology
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Massachusetts
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Boston, Massachusetts, 미국, 02114
- 아직 모집하지 않음
- Massachusetts General Hospital - Cardiology
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Michigan
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Detroit, Michigan, 미국, 48202
- 아직 모집하지 않음
- Henry Ford Hospital - Cardiology
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North Carolina
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Durham, North Carolina, 미국, 27704
- 아직 모집하지 않음
- Duke University Hospital - Cardiology
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Texas
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Fort Worth, Texas, 미국, 76104
- 아직 모집하지 않음
- Texas Health Heart and Vascular Specialists - Fort Worth
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Tyler, Texas, 미국, 75701
- 빼는
- CHRISTUS Trinity | Mother Frances Louis and Peaches Owen Heart Hospital - Electrophysiology Clinic
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Flemish Brabant
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Leuven, Flemish Brabant, 벨기에, 3000
- 아직 모집하지 않음
- UZ Leuven Gasthuisberg - Cardiology diseases department
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Limburg
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Hasselt, Limburg, 벨기에, 3500
- 아직 모집하지 않음
- Jessa Ziekenhuis | Hartcentrum Hasselt
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West Flanders
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Roeselare, West Flanders, 벨기에, 8800
- 아직 모집하지 않음
- AZ Delta | Clinical Trial Center - Cardiology
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Plovdiv Province
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Plovdiv, Plovdiv Province, 불가리아, 4001
- 아직 모집하지 않음
- 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, 불가리아, 1233
- 아직 모집하지 않음
- Multiprofile Hospital for Active Treatment Knyaginya Klementina Sofia EAD | Cardiology Department
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Sofia, Sofia City Province, 불가리아, 1527
- 아직 모집하지 않음
- 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, 불가리아, 5000
- 아직 모집하지 않음
- Multiprofile Hospital for Active Treatment Dr. Stefan Cherkezov | Base 1 - Cardiology Department
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Acquaviva delle Fonti, 이탈리아, 70021
- 아직 모집하지 않음
- Ente Ecclesiastico Ospedale Generale Regionale Miulli - Cardiologia e UTIC
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Milan, 이탈리아, 20138
- 모병
- Centro Cardiologico Monzino S.p.A. - UO Scompenso e Cardiologia Clinica
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Roma, 이탈리아, 00161
- 아직 모집하지 않음
- Azienda Ospedaliero-Universitaria Policlinico Umberto I - Malattie Cardiovascolari
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Torrette, 이탈리아, 60126
- 아직 모집하지 않음
- Azienda Ospedaliero Universitaria Delle Marche - Clinica di Cardiologia e Aritmologia
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Bielsko-Biala, 폴란드, 43-316
- 아직 모집하지 않음
- American Heart of Poland S.A. - PAKS Centrum Kardiologii i Kardiochirurgii w Bielsku-Białej - Oddział Kardiologii
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Chrzanów, 폴란드, 32-500
- 아직 모집하지 않음
- American Heart of Poland S.A. - MCSN, PAKS w Chrzanowie - Oddział Intensywnej Opieki Kardiologicznej
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Grodzisk Mazowiecki, 폴란드, 05-825
- 아직 모집하지 않음
- Samodzielny Publiczny Specjalistyczny Szpital Zachodni im. sw. Jana Pawla II
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Lublin, 폴란드, 20-090
- 아직 모집하지 않음
- USK nr 4 w Lublinie - Kliniczny Odd. Kardiologii, Reh. Kardio., Ch. Wew. z Pododdzialem Intensywnej Opieki Kardio.
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Budapest, 헝가리, 1122
- 아직 모집하지 않음
- Semmelweis Egyetem, Varosmajori Sziv- es Ergyogyaszati Klinika
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Tolna County
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Szekszárd, Tolna County, 헝가리, 7100
- 아직 모집하지 않음
- Tolna Vármegyei Balassa János Kórház - I. Belgyógyászati Osztály: Kardiológia, Nefrológia
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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위약 비교기: 위약
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intravenous (IV) treatment
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실험적: BAY 3670549
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intravenous (IV) treatment
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Participants who experienced Treatment Emergent Adverse Events (TEAE)s
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 8월 18일
기본 완료 (추정된)
2030년 5월 16일
연구 완료 (추정된)
2030년 5월 16일
연구 등록 날짜
최초 제출
2026년 5월 13일
QC 기준을 충족하는 최초 제출
2026년 6월 1일
처음 게시됨 (실제)
2026년 6월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 9월 9일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 9월 8일
마지막으로 확인됨
2026년 7월 29일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 22961
- 2025 (미국 NIH 보조금/계약: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- 2025-523807-31-00 (씨티스)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .