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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)

NCT05532046 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2024-03-12

No results posted yet for this study

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.

Conditions

Interventions

DRUG

BAY2413555 Dose 1

BAY2413555 Dose 1

DRUG

BAY2413555 Dose 2

BAY2413555 Dose 2

DRUG

Placebo to BAY2413555

Placebo to BAY2413555

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-20
Primary Completion
2023-03-31
Completion
2023-03-31
FDA Drug
Yes

Countries

  • United States
  • Denmark
  • Germany
  • Israel
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05532046 on ClinicalTrials.gov