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 NCT05532046

Timeline & Enrollment

Primary Outcome

Number of participants with treatment-emergent adverse events (TEAEs)

Summary

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.

ICD-10 Classifications