Chronic Heart FailurePhase 1REMOTE-HFNCT05532046
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)
A Phase 1 study testing BAY2413555 Dose 1 and BAY2413555 Dose 2 in people with Chronic Heart Failure, run by Bayer at 18 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- BAY2413555 Dose 1 and BAY2413555 Dose 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 18 sitesin 6 countries
- Study dates
- 20 Sep 2022to 31 Mar 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 34Show fewer
- 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
Trial locations and contacts
18 sites in 6 countries.
18 sites in 6 countries
Spain6 sites
Hospital Alvaro Cunqueiro | Cardiology Department
Babio - Beade, Pontevedra, 36312
Hospital del Mar | Cardiology Department
Barcelona, 08003
Hospital Universitari de Bellvitge | Bellvitge Biomedical Research Institute - Cardiology Department
Barcelona, 08907
Junta de Andalucía | University Hospital Reina Sofia - Cardiology Department
Córdoba, 14004
Hospital Universitario Virgen de la Victoria | Cardiology Department
Málaga, 29010
Hospital General Universitario de Valencia
Valencia, 46014
United States3 sites
Accel Research Sites - Atlanta Clinical Research Center
Atlanta, Georgia, 30342
Capital Area Research, LLC
Camp Hill, Pennsylvania, 17011
White Oak Medical Center
Silver Spring, Maryland, 20904
Denmark3 sites
Capital Region | Gentofte Hospital - Cardiology Research
Hellerup, 2900
Odense Universitetshospital, Hjertemedicinsk Amb.
Odense C, 5000
Zealand University Hospital | Roskilde - Cardiology Department
Roskilde, 4000
Israel3 sites
Barzilai Ashkelon University Medical Center | Cardiology Department
Ashkelon, 7830604
Rambam Health Care Campus | Internal Medicine - Cardiology Department
Haifa, 3109601
Ziv Medical Center | Cardiology Department
Safed, 1311001
Italy2 sites
Humanitas Research Hospital | Cardio Center - Clinical, Interventional Cardiology and Coronary Care
Milan, Lombardy, 20089
Fondazione Toscana Gabriele Monasterio | Heart Hospital Gaetano Pasquinucci - Cardiology Department
Pisa, Tuscany, 56124
About this study
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
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.
Read more
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
- Chronic Heart Failure
- Being tested
- BAY2413555 Dose 1, BAY2413555 Dose 2, Placebo to BAY2413555
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAY2413555 Dose 1Drug
BAY2413555 Dose 1
BAY2413555 Dose 2Drug
BAY2413555 Dose 2
Placebo to BAY2413555Drug
Placebo to BAY2413555
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm 1 | Experimental | Participants will receive BAY2413555 for 28 days (Part A: 14 days and Part B: 14 days). Receives: Drug: BAY2413555 Dose 1 |
| Treatment arm 2 | Experimental | Participants will receive BAY2413555 for 28 days (Part A: 14 days and Part B: 14 days). Receives: Drug: BAY2413555 Dose 1; Drug: BAY2413555 Dose 2 |
| Placebo | Placebo comparator | Participants will receive placebo to BAY2413555 for 28 days (Part A: 14 days and Part B: 14 days). Receives: Drug: Placebo to BAY2413555 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-emergent adverse events (TEAEs)
Measured: Up to 56 days
Secondary outcomes (2)
Number of participants with higher degree atrioventricular (AV) blocks, symptomatic pauses/bradycardia
Measured: Up to 28 days
Changes from baseline in resting heart rate (HR) after 2 and 4 weeks of dosing with BAY2413555
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start20 Sep 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Why it stopped: Due to new preclinical findings in a chronic toxicology study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05532046
- Sponsor's protocol ID
- 20623
- Other IDs
- 2021-005751-36
- Acronym
- REMOTE-HF
- Status last verified
- Mar 2024
- First submitted
- 5 Sep 2022
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05532046
- Acronym / sponsor ID
- REMOTE-HF / 20623
- Conditions
- Chronic Heart Failure
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to new preclinical findings in a chronic toxicology study.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 8 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment arm 1 | Experimental | Drug: BAY2413555 Dose 1Participants will receive BAY2413555 for 28 days (Part A: 14 days and Part B: 14 days). |
| Treatment arm 2 | Experimental | Drug: BAY2413555 Dose 1, Drug: BAY2413555 Dose 2Participants will receive BAY2413555 for 28 days (Part A: 14 days and Part B: 14 days). |
| Placebo | Placebo comparator | Drug: Placebo to BAY2413555Participants will receive placebo to BAY2413555 for 28 days (Part A: 14 days and Part B: 14 days). |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (34 listed)
- 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:
- Occurrence of any of the following within 4 weeks prior to Visit 1:
- Heart rate (HR) > 100 bpm at Screening Visit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAY2413555 Dose 1BAY2413555 Dose 1 | Drug | Treatment arm 1, Treatment arm 2 |
| BAY2413555 Dose 2BAY2413555 Dose 2 | Drug | Treatment arm 2 |
| Placebo to BAY2413555Placebo to BAY2413555 | Drug | Placebo |
Primary outcome
Number of participants with treatment-emergent adverse events (TEAEs)
Time frame: Up to 56 days
2 secondary outcomes
Number of participants with higher degree atrioventricular (AV) blocks, symptomatic pauses/bradycardia
Time frame: Up to 28 days
Changes from baseline in resting heart rate (HR) after 2 and 4 weeks of dosing with BAY2413555
Time frame: Up to 28 days
Results and safety
The study was stopped early (reason given: Due to new preclinical findings in a chronic toxicology study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: No. 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.
Related trials for Chronic Heart Failure
Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
Recruiting
Vasopressor Agents in Pulmonary Hypertension Crisis
Pulmonary Arterial Hypertension (PAH), Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 4
Empagliflozin in Heart Failure With Reduced Ejection Fraction and End Stage Renal Disease
Heart Failure With Reduced Ejection Fraction, End Stage Renal Disease on Dialysis
Not yet recruitingPhase 3
Efficacy of Lipoic Acid on Chronic Ischemic Heart Failure Patients
Heart Failure Due to Coronary Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BAY2413555 Dose 1 and BAY2413555 Dose 2 in people with Chronic Heart Failure, run by Bayer at 18 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Spain, United States, Denmark, Israel, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to new preclinical findings in a chronic toxicology study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-emergent adverse events (TEAEs) (time frame: Up to 56 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.