stop_circleTerminated/Withdrawn
Chronic heart failure
Bayer Identifier:
20623
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
A study to learn how safe study drug BAY2413555 is, how it affects the body, and how it moves into, through, and out of the body over 4 weeks of use in participants with heart failure and implanted cardiac defibrillator or cardiac resynchronization devices (ICD/CRT)
Trial purpose
Researchers are looking for a better way to treat people who have chronic heart failure. Chronic heart failure is a medical condition with shortness of breath, tiredness and ankle swelling in which the heart does not pump blood as well as it should.
BAY2413555 is a new compound which is under development for the treatment of heart failure. Heart failure is a serious disease in which the heart pumps less well. BAY2413555 is expected to protect the heart and improve cardiac function.
The main purpose of this study is to learn how safe BAY2413555 is compared to placebo in participants with chronic heart failure and implanted cardiac defibrillator, or cardiac resynchronization devices (ICD/CRT). A placebo is a treatment that looks like a medicine, but does not have any medicine in it. ICD/CRT are machines placed in the body that use an electric shock/impulse to reset the heart or get it beating correctly. To study the safety, the researchers will record all medical problems the participants may have during the study after starting the study treatment. Medical problems that happen after the participants have started their treatment are also known as “treatment emergent adverse events” (TEAEs). The TEAEs will be compared between participants who received BAY2413555 and those who received placebo.
The second purpose of this study is to learn whether BAY2413555 effects electrical signals inside the heart compared to placebo.
The study has two parts, A and B. Each part will last for two weeks. In part A, the participants will be assigned by chance to either take BAY2413555 as a tablet by mouth once per day or a placebo. Participants from part A who do not need to stop the study based on predefined criteria continue in part B. They will be assigned by chance to receive either the same dose of BAY2413555 as in part A or a higher dose. Participants who have taken placebo in part A will as well be assigned in part B.
Each participant will be in the study for approximately 90 days (including the screening period and follow-up period). In the study, participants will take study medication for 28 days. 8 visits to the study site and 1 telephone contact visit are planned. During the study, the study team will:
• do physical examinations
• check vital signs
• examine heart health using ECG
• check the participants’ ICD/CRT information
• take exercise testing
• take blood and urine samples
• ask the participants questions about how they are feeling about their quality of life
• ask the participants questions about how they are feeling and what
adverse events they are having.
An adverse event is any problem that happens during the trial. Doctors keep track of all adverse events that happen in trials, even if they do not think the adverse events might be related to the study treatments or a study procedure. Participants will be closely monitored during the entire study duration and site personnel will take action to mitigate any negative effect, if any, as appropriate.
About 30 days after the participants take their last treatment, the study doctors and their team will check the participants’ health.
BAY2413555 is a new compound which is under development for the treatment of heart failure. Heart failure is a serious disease in which the heart pumps less well. BAY2413555 is expected to protect the heart and improve cardiac function.
The main purpose of this study is to learn how safe BAY2413555 is compared to placebo in participants with chronic heart failure and implanted cardiac defibrillator, or cardiac resynchronization devices (ICD/CRT). A placebo is a treatment that looks like a medicine, but does not have any medicine in it. ICD/CRT are machines placed in the body that use an electric shock/impulse to reset the heart or get it beating correctly. To study the safety, the researchers will record all medical problems the participants may have during the study after starting the study treatment. Medical problems that happen after the participants have started their treatment are also known as “treatment emergent adverse events” (TEAEs). The TEAEs will be compared between participants who received BAY2413555 and those who received placebo.
The second purpose of this study is to learn whether BAY2413555 effects electrical signals inside the heart compared to placebo.
The study has two parts, A and B. Each part will last for two weeks. In part A, the participants will be assigned by chance to either take BAY2413555 as a tablet by mouth once per day or a placebo. Participants from part A who do not need to stop the study based on predefined criteria continue in part B. They will be assigned by chance to receive either the same dose of BAY2413555 as in part A or a higher dose. Participants who have taken placebo in part A will as well be assigned in part B.
Each participant will be in the study for approximately 90 days (including the screening period and follow-up period). In the study, participants will take study medication for 28 days. 8 visits to the study site and 1 telephone contact visit are planned. During the study, the study team will:
• do physical examinations
• check vital signs
• examine heart health using ECG
• check the participants’ ICD/CRT information
• take exercise testing
• take blood and urine samples
• ask the participants questions about how they are feeling about their quality of life
• ask the participants questions about how they are feeling and what
adverse events they are having.
An adverse event is any problem that happens during the trial. Doctors keep track of all adverse events that happen in trials, even if they do not think the adverse events might be related to the study treatments or a study procedure. Participants will be closely monitored during the entire study duration and site personnel will take action to mitigate any negative effect, if any, as appropriate.
About 30 days after the participants take their last treatment, the study doctors and their team will check the participants’ health.
Key Participants Requirements
Sex
AllAge
18 - 79 YearsTrial summary
Enrollment Goal
22Trial Dates
September 2022 - March 2023Phase
Phase 1Could I Receive a placebo
YesProducts
BAY2413555Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Withdrawn | Universitätsmedizin Greifswald | Innere Medizin B | Greifswald, 17489, Germany |
Withdrawn | Ev. Krankenhaus Hagen-Haspe|Kardiologie und Rhythmologie | Hagen, 58135, Germany |
Withdrawn | Klinikum Singen|Kardiologie und internistische Intensivmediz | Singen, 78224, Germany |
Completed | Pratia | Klinische Forschung Dresden | Dresden, 01069, Germany |
Withdrawn | Klinische Forschung Schwerin GmbH | Schwerin, 19055, Germany |
Withdrawn | Georg August UniGoettingen | Kardiologie und Pneumologie | Göttingen, 37075, Germany |
Withdrawn | Golden Jubilee National Hospital | Clydebank, G81 4DY, United Kingdom |
Withdrawn | University Hospitals Coventry and Warwickshire NHS Trust | Coventry, CV2 2DX, United Kingdom |
Withdrawn | Ninewells Hospital and Medical School | Dundee, DD1 9SY, United Kingdom |
Withdrawn | Hammersmith Hospital | London, W12 0HS, United Kingdom |
Withdrawn | Blackpool Victoria Hospital | Blackpool, FY3 8NR, United Kingdom |
Withdrawn | South Oklahoma Heart Research, LLC | Oklahoma City, 73135, United States |
Withdrawn | University of Nebraska Medical Center | Omaha, 68105, United States |
Completed | White Oak Medical Center | Silver Spring, 20904, United States |
Completed | Capital Area Research, LLC | Camp Hill, 17011, United States |
Completed | Accel Research Sites - Atlanta Clinical Research Center | Atlanta, 30342, United States |
Completed | Humanitas Research Hospital | Cardio Center - Clinical, Interventional Cardiology and Coronary Care | Milano, 20089, Italy |
Withdrawn | ASST Spedali Civili di Brescia | Brescia, 25123, Italy |
Completed | Fondazione Toscana Gabriele Monasterio | Heart Hospital Gaetano Pasquinucci - Cardiology Department | Pisa, 56124, Italy |
Withdrawn | ASST Papa Giovanni XXIII | Bergamo, 24127, Italy |
Withdrawn | La Fe University and Polytechnic Hospital | Unidad de Insuficiencia Cardiaca y Trasplante | Valencia, 46026, Spain |
Completed | Hospital del Mar | Cardiology Department | Barcelona, 08003, Spain |
Completed | Hospital Alvaro Cunqueiro | Cardiology Department | Babio - Beade, 36312, Spain |
Completed | Hospital General Universitario de Valencia | Valencia, 46014, Spain |
Completed | Hospital Universitario Virgen de la Victoria | Cardiology Department | Málaga, 29010, Spain |
Completed | Junta de Andalucía | University Hospital Reina Sofia - Cardiology Department | Córdoba, 14004, Spain |
Completed | Hospital Universitari de Bellvitge | Bellvitge Biomedical Research Institute - Cardiology Department | Barcelona, 08907, Spain |
Withdrawn | Rigshospitalet | København Ø, 2100, Denmark |
Completed | Capital Region | Gentofte Hospital - Cardiology Research | Hellerup, 2900, Denmark |
Completed | Zealand University Hospital | Roskilde - Cardiology Department | Roskilde, 4000, Denmark |
Completed | Odense Universitetshospital, Hjertemedicinsk Amb. | Odense C, 5000, Denmark |
Withdrawn | Aarhus Universitetshospital, Skejby | Aarhus N, 8200, Denmark |
Withdrawn | Nemocnice Ceske Budejovice, a.s. Department of kardiologie | Ceske Budejovice, 370 01, Czechia |
Withdrawn | Fakultni nemocnice Brno | Brno, 625 00, Czechia |
Withdrawn | Ustredni vojenska nemocnice Praha | Praha 6, 169 02, Czechia |
Withdrawn | Institut Klinicke a Experimentalni Mediciny | Praha 4, 140 21, Czechia |
Withdrawn | Vseobecna fakultni nemocnice v Praze | Praha 2, 12808, Czechia |
Withdrawn | Shamir Medical Center (Assaf Harofeh) | Zrifin, 7030000, Israel |
Completed | Rambam Health Care Campus | Internal Medicine - Cardiology Department | Haifa, 3109601, Israel |
Completed | Barzilai Ashkelon University Medical Center | Cardiology Department | Ashkelon, 7830604, Israel |
Completed | Ziv Medical Center | Cardiology Department | Zefat, 1311001, Israel |
Withdrawn | Health Corporation of Galilee Medical Center | Nahariya, 22100, Israel |
Withdrawn | Shaare Zedek Medical Center | Jerusalem, 9103102, Israel |
Withdrawn | Duke University Medical Center | Durham, 27710, United States |
Withdrawn | Medizinische Universität Graz | Graz, 8036, Austria |
Withdrawn | Universitätsklinikum St. Pölten | St. Pölten, 3100, Austria |
Withdrawn | Medizinische Universität Innsbruck | Innsbruck, 6020, Austria |
Withdrawn | Imed19-privat | Wien, 1190, Austria |
Withdrawn | UMHAT Prof. Dr Aleksandar Chirkov | Sofia, 1431, Bulgaria |
Withdrawn | UMHAT Alexandrovska EAD | Sofia, 1431, Bulgaria |
Withdrawn | Acibadem City Clinic Multiprofile Hospital for Active Treatm | Sofia, 1407, Bulgaria |
Withdrawn | University of Semmelweis/ Semmelweis Egyetem | Budapest, 1122, Hungary |
Withdrawn | Debreceni Egyetem Klinikai Kozpont | Debrecen, 4032, Hungary |
Withdrawn | PTE KK I Belgy Klinika Klinikai Farmakologiai Tanszek | Pecs, 7624, Hungary |
Withdrawn | Hopital Europeen Georges Pompidou – Service de Cardiologie | Paris, 75015, France |
Withdrawn | Hôpital Louis Pradel - Bron | BRON CEDEX, 69677, France |
Withdrawn | CHU de Grenoble – Service de Cardiologie | La Tronche, 38700, France |
Withdrawn | CHU Rennes, H Pontchaillou, Cardiologie | Rennes, 35033, France |
Withdrawn | University Hospital of Wales | Cardiff, CF14 4XW, United Kingdom |
Withdrawn | Universitätsklinikum AKH Wien | Wien, 1090, Austria |
Withdrawn | UMHAT Sveti Georgi | Plovdiv, 4000, Bulgaria |
Primary Outcome
- Number of participants with treatment-emergent adverse events (TEAEs)date_rangeTime Frame:Up to 56 days
Secondary Outcome
- Number of participants with higher degree atrioventricular (AV) blocks, symptomatic pauses/bradycardiadate_rangeTime Frame:Up to 28 days
- Changes from baseline in resting heart rate (HR) after 2 and 4 weeks of dosing with BAY2413555date_rangeTime Frame:Up to 28 days
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
3