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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Faza 2
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Bayer Clinical Trials Contact
- Numer telefonu: 18888422937
- E-mail: clinical-trials-contact@bayer.com
Lokalizacje studiów
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Flemish Brabant
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Leuven, Flemish Brabant, Belgia, 3000
- Rekrutacyjny
- UZ Leuven Gasthuisberg - Cardiology diseases department
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Limburg
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Hasselt, Limburg, Belgia, 3500
- Jeszcze nie rekrutacja
- Jessa Ziekenhuis | Hartcentrum Hasselt
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West Flanders
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Roeselare, West Flanders, Belgia, 8800
- Jeszcze nie rekrutacja
- AZ Delta | Clinical Trial Center - Cardiology
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Plovdiv Province
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Plovdiv, Plovdiv Province, Bułgaria, 4001
- Jeszcze nie rekrutacja
- 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, Bułgaria, 1233
- Jeszcze nie rekrutacja
- Multiprofile Hospital for Active Treatment Knyaginya Klementina Sofia EAD | Cardiology Department
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Sofia, Sofia City Province, Bułgaria, 1527
- Rekrutacyjny
- 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, Bułgaria, 5000
- Rekrutacyjny
- Multiprofile Hospital for Active Treatment Dr. Stefan Cherkezov | Base 1 - Cardiology Department
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Groningen, Holandia, 9713 GZ
- Jeszcze nie rekrutacja
- Universitair Medisch Centrum Groningen
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Limburg
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Maastricht, Limburg, Holandia, 6229 HX
- Jeszcze nie rekrutacja
- Maastricht UMC
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Lower Saxony
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Hanover, Lower Saxony, Niemcy, 30625
- Jeszcze nie rekrutacja
- Medizinische Hochschule Hannover|Kardiologie und Angiologie
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North Rhine-Westphalia
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Bad Oeynhausen, North Rhine-Westphalia, Niemcy, 32545
- Jeszcze nie rekrutacja
- Herz-und Diabeteszentrum NRW|Elektrophysiologie/Rhythmologie
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Thuringia
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Altenburg, Thuringia, Niemcy, 04600
- Rekrutacyjny
- Klinikum Altenburger Land GmbH-Klinik für Kardiologie, Pneumologie und Internistische Intensivmedizin
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Lesser Poland Voivodeship
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Chrzanów, Lesser Poland Voivodeship, Polska, 32-500
- Jeszcze nie rekrutacja
- 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, Polska, 20-090
- Jeszcze nie rekrutacja
- 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, Polska, 05-825
- Rekrutacyjny
- Samodzielny Publiczny Specjalistyczny Szpital Zachodni im. sw. Jana Pawla II
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Silesian Voivodeship
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Bielsko-Biala, Silesian Voivodeship, Polska, 43-316
- Jeszcze nie rekrutacja
- American Heart of Poland S.A. - PAKS Centrum Kardiologii i Kardiochirurgii w Bielsku-Białej - Oddział Kardiologii
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California
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San Francisco, California, Stany Zjednoczone, 94143
- Wycofane
- UCSF Advanced Heart Failure Comprehensive Care Center
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Colorado
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Aurora, Colorado, Stany Zjednoczone, 80045
- Jeszcze nie rekrutacja
- UCHealth University of Colorado Hospital - Cardiology
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Massachusetts
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Boston, Massachusetts, Stany Zjednoczone, 02114
- Jeszcze nie rekrutacja
- Massachusetts General Hospital - Cardiology
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Michigan
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Detroit, Michigan, Stany Zjednoczone, 48202
- Rekrutacyjny
- Henry Ford Hospital - Cardiology
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Minnesota
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Maplewood, Minnesota, Stany Zjednoczone, 55109
- Wycofane
- M Health Fairview Heart Clinic - Maplewood
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North Carolina
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Durham, North Carolina, Stany Zjednoczone, 27704
- Jeszcze nie rekrutacja
- Duke University Hospital - Cardiology
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Texas
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Fort Worth, Texas, Stany Zjednoczone, 76104
- Jeszcze nie rekrutacja
- Texas Health Heart and Vascular Specialists - Fort Worth
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Tyler, Texas, Stany Zjednoczone, 75701
- Jeszcze nie rekrutacja
- CHRISTUS Trinity | Mother Frances Louis and Peaches Owen Heart Hospital - Electrophysiology Clinic
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Budapest, Węgry, 1122
- Rekrutacyjny
- Semmelweis Egyetem, Varosmajori Sziv- és Ergyogyaszati Klinika
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Tolna County
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Szekszárd, Tolna County, Węgry, 7100
- Jeszcze nie rekrutacja
- Tolna Vármegyei Balassa János Kórház - I. Belgyógyászati Osztály: Kardiológia, Nefrológia
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Apulia
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Acquaviva delle Fonti, Apulia, Włochy, 70021
- Rekrutacyjny
- Ente Ecclesiastico Ospedale Generale Regionale Miulli - Cardiologia e UTIC
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Lazio
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Rome, Lazio, Włochy, 00161
- Jeszcze nie rekrutacja
- Azienda Ospedaliero-Universitaria Policlinico Umberto I - Malattie Cardiovascolari
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Lombardy
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Milan, Lombardy, Włochy, 20138
- Rekrutacyjny
- Centro Cardiologico Monzino S.p.A. - UO Scompenso e Cardiologia Clinica
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The Marches
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Torrette, The Marches, Włochy, 60126
- Jeszcze nie rekrutacja
- Azienda Ospedaliero Universitaria Delle Marche - Clinica di Cardiologia e Aritmologia
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Komparator placebo: Placebo
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intravenous (IV) treatment |
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Eksperymentalny: BAY 3670549
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intravenous (IV) treatment |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
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
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Number of Participants who experienced Treatment Emergent Adverse Events (TEAE)s
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 22961
- 2025-523807-31-00 (Ctis)
- 2025 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu 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.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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