A Study to Test How Well BAY 3670549 Works and How Safe it is in Patients With Atrial Fibrillation (CARDIOVERT)
8 september 2026 uppdaterad av: 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
360
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Bayer Clinical Trials Contact
- Telefonnummer: 18888422937
- E-post: clinical-trials-contact@bayer.com
Studieorter
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Flemish Brabant
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Leuven, Flemish Brabant, Belgien, 3000
- Har inte rekryterat ännu
- UZ Leuven Gasthuisberg - Cardiology diseases department
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Limburg
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Hasselt, Limburg, Belgien, 3500
- Har inte rekryterat ännu
- Jessa Ziekenhuis | Hartcentrum Hasselt
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West Flanders
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Roeselare, West Flanders, Belgien, 8800
- Har inte rekryterat ännu
- AZ Delta | Clinical Trial Center - Cardiology
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Plovdiv Province
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Plovdiv, Plovdiv Province, Bulgarien, 4001
- Har inte rekryterat ännu
- 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, Bulgarien, 1233
- Har inte rekryterat ännu
- Multiprofile Hospital for Active Treatment Knyaginya Klementina Sofia EAD | Cardiology Department
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Sofia, Sofia City Province, Bulgarien, 1527
- Har inte rekryterat ännu
- 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, Bulgarien, 5000
- Har inte rekryterat ännu
- Multiprofile Hospital for Active Treatment Dr. Stefan Cherkezov | Base 1 - Cardiology Department
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California
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San Francisco, California, Förenta staterna, 94143
- Indragen
- UCSF Advanced Heart Failure Comprehensive Care Center
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Colorado
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Aurora, Colorado, Förenta staterna, 80045
- Har inte rekryterat ännu
- UCHealth University of Colorado Hospital - Cardiology
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02114
- Har inte rekryterat ännu
- Massachusetts General Hospital - Cardiology
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Michigan
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Detroit, Michigan, Förenta staterna, 48202
- Har inte rekryterat ännu
- Henry Ford Hospital - Cardiology
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North Carolina
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Durham, North Carolina, Förenta staterna, 27704
- Har inte rekryterat ännu
- Duke University Hospital - Cardiology
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Texas
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Fort Worth, Texas, Förenta staterna, 76104
- Har inte rekryterat ännu
- Texas Health Heart and Vascular Specialists - Fort Worth
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Tyler, Texas, Förenta staterna, 75701
- Indragen
- CHRISTUS Trinity | Mother Frances Louis and Peaches Owen Heart Hospital - Electrophysiology Clinic
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Acquaviva delle Fonti, Italien, 70021
- Har inte rekryterat ännu
- Ente Ecclesiastico Ospedale Generale Regionale Miulli - Cardiologia e UTIC
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Milan, Italien, 20138
- Rekrytering
- Centro Cardiologico Monzino S.p.A. - UO Scompenso e Cardiologia Clinica
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Roma, Italien, 00161
- Har inte rekryterat ännu
- Azienda Ospedaliero-Universitaria Policlinico Umberto I - Malattie Cardiovascolari
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Torrette, Italien, 60126
- Har inte rekryterat ännu
- Azienda Ospedaliero Universitaria Delle Marche - Clinica di Cardiologia e Aritmologia
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Groningen, Nederländerna, 9713 GZ
- Har inte rekryterat ännu
- Universitair Medisch Centrum Groningen
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Limburg
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Maastricht, Limburg, Nederländerna, 6229 HX
- Har inte rekryterat ännu
- Maastricht UMC
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Bielsko-Biala, Polen, 43-316
- Har inte rekryterat ännu
- American Heart of Poland S.A. - PAKS Centrum Kardiologii i Kardiochirurgii w Bielsku-Białej - Oddział Kardiologii
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Chrzanów, Polen, 32-500
- Har inte rekryterat ännu
- American Heart of Poland S.A. - MCSN, PAKS w Chrzanowie - Oddział Intensywnej Opieki Kardiologicznej
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Grodzisk Mazowiecki, Polen, 05-825
- Har inte rekryterat ännu
- Samodzielny Publiczny Specjalistyczny Szpital Zachodni im. sw. Jana Pawla II
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Lublin, Polen, 20-090
- Har inte rekryterat ännu
- USK nr 4 w Lublinie - Kliniczny Odd. Kardiologii, Reh. Kardio., Ch. Wew. z Pododdzialem Intensywnej Opieki Kardio.
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Lower Saxony
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Hanover, Lower Saxony, Tyskland, 30625
- Har inte rekryterat ännu
- Medizinische Hochschule Hannover|Kardiologie und Angiologie
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North Rhine-Westphalia
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Bad Oeynhausen, North Rhine-Westphalia, Tyskland, 32545
- Har inte rekryterat ännu
- Herz-und Diabeteszentrum NRW|Elektrophysiologie/Rhythmologie
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Thuringia
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Altenburg, Thuringia, Tyskland, 04600
- Har inte rekryterat ännu
- Klinikum Altenburger Land GmbH-Klinik für Kardiologie, Pneumologie und Internistische Intensivmedizin
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Budapest, Ungern, 1122
- Har inte rekryterat ännu
- Semmelweis Egyetem, Varosmajori Sziv- es Ergyogyaszati Klinika
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Tolna County
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Szekszárd, Tolna County, Ungern, 7100
- Har inte rekryterat ännu
- Tolna Vármegyei Balassa János Kórház - I. Belgyógyászati Osztály: Kardiológia, Nefrológia
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Placebo-jämförare: Placebo
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intravenous (IV) treatment
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Experimentell: BAY 3670549
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intravenous (IV) treatment
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Number of Participants who experienced Treatment Emergent Adverse Events (TEAE)s
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
18 augusti 2026
Primärt slutförande (Beräknad)
16 maj 2030
Avslutad studie (Beräknad)
16 maj 2030
Studieregistreringsdatum
Först inskickad
13 maj 2026
Först inskickad som uppfyllde QC-kriterierna
1 juni 2026
Första postat (Faktisk)
4 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
9 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 september 2026
Senast verifierad
29 juli 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 22961
- 2025 (U.S.S. NIH-anslag/kontrakt: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- 2025-523807-31-00 (Ctis)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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