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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) (REMOTE-HF)

Primary Purpose

Chronic Heart Failure

Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
BAY2413555 Dose 1
BAY2413555 Dose 2
Placebo to BAY2413555
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Providing signed informed consent
  • Diagnosis of heart failure lasting for at least 3 months, New York Heart Association (NYHA) functional class I-III prior to Visit 1
  • Left ventricular ejection fraction (LVEF) ≤ 45% as documented by any imaging modality within the past 12 months prior to Visit 1
  • Treatment with Guideline-Directed Medical Therapy Including with mandatory betablocker treatment with either Metoprolol, Carvedilol, Bisoprolol or Nebivolol on stable, highest individually tolerated dose for at least 2 weeks prior to Visit 1

  • Implanted cardiac defibrillator (ICD) with pacemaker backup function OR cardiac resynchronization device (CRT)

    • first implantation at least 3 months prior to Visit 1

Exclusion Criteria:

  • Permanent atrial fibrillation or other than Sinus rhythm at Visit 1
  • History of higher degree atrioventricular (AV) block (Mobitz type II or third-degree AV block) within 4 weeks prior to Visit 1

  • Indication for or planned procedure:

    • Planned cardiac surgery, carotid angioplasty or surgery, transcatheter aortic valve implantation (TAVI) or mitral valve clipping within 3 months starting from the Screening Visit
    • Percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or implantation of a cardiac resynchronization therapy defibrillator device indicated at Screening or planned within 3 months starting from the Screening Visit
    • Valvular Disease Repair indicated at Screening or planned within 3 months starting from the Screening Visit.

  • Occurrence of any of the following within 4 weeks prior to Visit 1:

    • Myocardial infarction
    • Stroke or transient ischemic attack (TIA)
    • coronary artery bypass graft (CABG)
    • percutaneous coronary intervention (PCI)
    • Carotid angioplasty
    • Ablation therapy of atrial fibrillation or other rhythm abnormalities
  • Heart rate (HR) > 100 bpm at Screening Visit
  • Restrictive, infiltrative or hypertrophic cardiomyopathy, constrictive pericarditis, acute myocarditis within 3 months prior to Visit 1
  • Malignancy of the hematological system within 5 years prior to the Screening Visit
  • Listed for heart transplantation and/or anticipated implantation of a ventricular assist device at the Screening Visit
  • Hepatic insufficiency classified as Child-Pugh B or C at the Screening Visit
  • Estimated (according to the investigator's judgement) inability to perform exercise testing

  • Any of the following from the blood sample taken at the Screening Visit

    • Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m^2 (calculated according to the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation)
    • Hemoglobin < 11 g/dL
    • White blood cell (WBC) < 3000/mm^3
    • Thrombocytes < 100 000/mm^3
  • Currently receiving or planned to receive dialysis or ultrafiltration
  • Chronic obstructive pulmonary disease (COPD) Stage 3 or 4 (GOLD criteria), requiring treatment, or symptomatic asthma requiring current treatment
  • Prior or concomitant therapy with cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors or inducers.

Relevant substances need to be discontinued

  • at least 2 weeks before randomization for CYP3A4 inducers
  • at least 5 half-lives before randomization for CYP3A4 inhibitors Restarting of these therapies is possible 28 days after last intake of study intervention. This criterion also applies to other inhibitors of CYP3A4, e.g., grapefruit.

Prior and concomitant therapy with amiodarone is allowed.

  • Concomitant treatment with acetylcholine esterase inhibitors within 4 weeks prior to Visit 1
  • Use of other investigational drugs. Previous (within 4 weeks, or 5 half-lives of the investigational drug, whichever is longer, prior to Visit 1) or concomitant participation in another clinical study with investigational medicinal product(s) or device(s)
  • Life expectancy < 6 months at the Screening Visit

Sites / Locations

  • Accel Research Sites - Atlanta Clinical Research Center
  • White Oak Medical Center
  • Capital Area Research, LLC
  • Capital Region | Gentofte Hospital - Cardiology Research
  • Odense Universitetshospital, Hjertemedicinsk Amb.
  • Sjællands Universitetshospital Roskilde
  • Klinische Forschung Dresden GmbH
  • Barzilai Medical Center | Cardiology Department
  • Rambam Health Corporation
  • Health Corporation of the Ziv Medical Center (R.A.)
  • Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.
  • Fondazione Toscana Gabriele Monasterio (FTGM)
  • Hospital Alvaro Cunqueiro | Cardiology Department
  • Hospital del Mar | Cardiology Department
  • Hospital Universitari de Bellvitge | Bellvitge Biomedical Research Institute - Cardiology Department
  • Junta de Andalucía | University Hospital Reina Sofia - Cardiology Department
  • Hospital Virgen de la Victoria
  • Hospital General Universitario de Valencia

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Treatment arm 1

Treatment arm 2

Placebo

Arm Description

Participants will receive BAY2413555 for 28 days (Part A: 14 days and Part B: 14 days).

Participants will receive BAY2413555 for 28 days (Part A: 14 days and Part B: 14 days).

Participants will receive placebo to BAY2413555 for 28 days (Part A: 14 days and Part B: 14 days).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of participants with higher degree atrioventricular (AV) blocks, symptomatic pauses/bradycardia
Changes from baseline in resting heart rate (HR) after 2 and 4 weeks of dosing with BAY2413555

Full Information

First Posted
September 5, 2022
Last Updated
May 5, 2023
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT05532046
Brief Title
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)
Acronym
REMOTE-HF
Official Title
A Phase 1b Double-blind, Randomized, Placebo-controlled, Multicenter, Dose Titration Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of 4 Weeks Treatment With BAY 2413555 in Participants With Heart Failure and Implanted Cardiac Defibrillator or Cardiac Resynchronization Devices
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
Due to new preclinical findings in a chronic toxicology study.
Study Start Date
September 20, 2022 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
March 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment arm 1
Arm Type
Experimental
Arm Description
Participants will receive BAY2413555 for 28 days (Part A: 14 days and Part B: 14 days).
Arm Title
Treatment arm 2
Arm Type
Experimental
Arm Description
Participants will receive BAY2413555 for 28 days (Part A: 14 days and Part B: 14 days).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo to BAY2413555 for 28 days (Part A: 14 days and Part B: 14 days).
Intervention Type
Drug
Intervention Name(s)
BAY2413555 Dose 1
Intervention Description
BAY2413555 Dose 1
Intervention Type
Drug
Intervention Name(s)
BAY2413555 Dose 2
Intervention Description
BAY2413555 Dose 2
Intervention Type
Drug
Intervention Name(s)
Placebo to BAY2413555
Intervention Description
Placebo to BAY2413555
Primary Outcome Measure Information:
Title
Number of participants with treatment-emergent adverse events (TEAEs)
Time Frame
Up to 56 days
Secondary Outcome Measure Information:
Title
Number of participants with higher degree atrioventricular (AV) blocks, symptomatic pauses/bradycardia
Time Frame
Up to 28 days
Title
Changes from baseline in resting heart rate (HR) after 2 and 4 weeks of dosing with BAY2413555
Time Frame
Up to 28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Providing signed informed consent Diagnosis of heart failure lasting for at least 3 months, New York Heart Association (NYHA) functional class I-III prior to Visit 1 Left ventricular ejection fraction (LVEF) ≤ 45% as documented by any imaging modality within the past 12 months prior to Visit 1 Treatment with Guideline-Directed Medical Therapy Including with mandatory betablocker treatment with either Metoprolol, Carvedilol, Bisoprolol or Nebivolol on stable, highest individually tolerated dose for at least 2 weeks prior to Visit 1 Implanted cardiac defibrillator (ICD) with pacemaker backup function OR cardiac resynchronization device (CRT) first implantation at least 3 months prior to Visit 1 Exclusion Criteria: Permanent atrial fibrillation or other than Sinus rhythm at Visit 1 History of higher degree atrioventricular (AV) block (Mobitz type II or third-degree AV block) within 4 weeks prior to Visit 1 Indication for or planned procedure: Planned cardiac surgery, carotid angioplasty or surgery, transcatheter aortic valve implantation (TAVI) or mitral valve clipping within 3 months starting from the Screening Visit Percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or implantation of a cardiac resynchronization therapy defibrillator device indicated at Screening or planned within 3 months starting from the Screening Visit Valvular Disease Repair indicated at Screening or planned within 3 months starting from the Screening Visit. Occurrence of any of the following within 4 weeks prior to Visit 1: Myocardial infarction Stroke or transient ischemic attack (TIA) coronary artery bypass graft (CABG) percutaneous coronary intervention (PCI) Carotid angioplasty Ablation therapy of atrial fibrillation or other rhythm abnormalities Heart rate (HR) > 100 bpm at Screening Visit Restrictive, infiltrative or hypertrophic cardiomyopathy, constrictive pericarditis, acute myocarditis within 3 months prior to Visit 1 Malignancy of the hematological system within 5 years prior to the Screening Visit Listed for heart transplantation and/or anticipated implantation of a ventricular assist device at the Screening Visit Hepatic insufficiency classified as Child-Pugh B or C at the Screening Visit Estimated (according to the investigator's judgement) inability to perform exercise testing Any of the following from the blood sample taken at the Screening Visit Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m^2 (calculated according to the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation) Hemoglobin < 11 g/dL White blood cell (WBC) < 3000/mm^3 Thrombocytes < 100 000/mm^3 Currently receiving or planned to receive dialysis or ultrafiltration Chronic obstructive pulmonary disease (COPD) Stage 3 or 4 (GOLD criteria), requiring treatment, or symptomatic asthma requiring current treatment Prior or concomitant therapy with cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors or inducers. Relevant substances need to be discontinued at least 2 weeks before randomization for CYP3A4 inducers at least 5 half-lives before randomization for CYP3A4 inhibitors Restarting of these therapies is possible 28 days after last intake of study intervention. This criterion also applies to other inhibitors of CYP3A4, e.g., grapefruit. Prior and concomitant therapy with amiodarone is allowed. Concomitant treatment with acetylcholine esterase inhibitors within 4 weeks prior to Visit 1 Use of other investigational drugs. Previous (within 4 weeks, or 5 half-lives of the investigational drug, whichever is longer, prior to Visit 1) or concomitant participation in another clinical study with investigational medicinal product(s) or device(s) Life expectancy < 6 months at the Screening Visit
Facility Information:
Facility Name
Accel Research Sites - Atlanta Clinical Research Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
White Oak Medical Center
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20904
Country
United States
Facility Name
Capital Area Research, LLC
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
Capital Region | Gentofte Hospital - Cardiology Research
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark
Facility Name
Odense Universitetshospital, Hjertemedicinsk Amb.
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Sjællands Universitetshospital Roskilde
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Klinische Forschung Dresden GmbH
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01069
Country
Germany
Facility Name
Barzilai Medical Center | Cardiology Department
City
Ashkelon
ZIP/Postal Code
7830604
Country
Israel
Facility Name
Rambam Health Corporation
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Health Corporation of the Ziv Medical Center (R.A.)
City
Zefat
ZIP/Postal Code
1311001
Country
Israel
Facility Name
Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20089
Country
Italy
Facility Name
Fondazione Toscana Gabriele Monasterio (FTGM)
City
Massa-Carrara
State/Province
Toscana
ZIP/Postal Code
54100
Country
Italy
Facility Name
Hospital Alvaro Cunqueiro | Cardiology Department
City
Babio - Beade
State/Province
Pontevedra
ZIP/Postal Code
36312
Country
Spain
Facility Name
Hospital del Mar | Cardiology Department
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Universitari de Bellvitge | Bellvitge Biomedical Research Institute - Cardiology Department
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Junta de Andalucía | University Hospital Reina Sofia - Cardiology Department
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Virgen de la Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.vivli.org 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 member section of the portal.
Links:
URL
https://clinicaltrials.bayer.com/
Description
Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

Learn more about this trial

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)

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