Chronic Heart FailureNCT05666518
A Study to Learn More About the Safety of the Drug Vericiguat in Japanese People With Chronic Heart Failure Who Will be Receiving Vericiguat Under Real-world Conditions
An observational study of Chronic Heart Failure, run by Bayer at 1 site in Japan.
Trial summary
This is an observational study in which data from Japanese people with chronic heart failure who will be receiving vericiguat is studied. Chronic heart failure (HF) is a long-term condition where the heart does not pump blood as well as it should. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- Vericiguat (Verquvo, BAY1021189)
- How many people
- 1,400 participants
- Where
- 1 siteJapan
- Study dates
- 31 Aug 2022to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population is composed of Japanese patients with chronic heart failure have been prescribed vericiguat or standard treatment by the physician.
Who may be able to join
- vericiguat arm:
- Patients receiving standard treatment for chronic heart failure, and vericiguat will be treated in accordance with the package insert (no history of receiving vericiguat)
- Patients who gave written consent to this investigation
- control arm:
- Patients receiving standard treatment for chronic heart failure according to the package insert of vericiguat as following (no history of receiving vericiguat)
- Prior (within 6 months) heart failure hospitalization or prior (within 3 months) intravenous (IV) diuretics for heart failure not requiring hospitalization (This will be applied only for the first ~75% of patients meeting this criteria to be enrolled.) Note: No more than approximately 25% of patients without a qualifying history of prior heart failure hospitalization within 6 months or prior IV diuretics for heart failure not requiring hospitalization within 3 months can be enrolled in the study.
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- New York Heart Association (NYHA) Classification: Class II to Class IV
- Left ventricular ejection fraction (LVEF): less than 45%
- Patients who gave written informed consent to this study
Who cannot join
- vericiguat arm:
- Patients who are participating in an interventional study
- control arm:
- Patients who have started or are scheduled to start therapy with vericiguat for chronic heart failure
- Patients who are participating in an interventional study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
Japanese registries
Multiple Locations, Many Locations
About this study
Official title: Vericiguat Drug Use Two-arm Investigation in Chronic Heart Failure
This is an observational study in which data from Japanese people with chronic heart failure who will be receiving vericiguat is studied.
Chronic heart failure (HF) is a long-term condition where the heart does not pump blood as well as it should. Heart failure can lead to other serious medical conditions, and it can lead to hospitalization or death.
Read more
The drug vericiguat works by increasing the activity of an enzyme called soluble guanylate cyclase (sGC). The sGC enzyme helps regulate the heart and blood circulation. Vericiguat is already available and approved for doctors to prescribe to people who have heart failure. A limited number of patients have been treated with vericiguat. Therefore information about its safety in a broader population and especially among Japanese people as well as for prolonged periods of treatment is still missing.
In this study, the researchers want to learn more about how safe vericiguat is if used in Japanese people with long term HF. To see how safe vericiguat is, the researchers will collect the medical problems the participants have during the treatment with vericiguat under real-word conditions. They will particularly focus on the following:
- high blood pressure
- any medical problems due to combination of the study treatment vericiguat with nitrates and nitric oxide (NO) donors or with PDE5 inhibitors
- medical problems in participants with liver problems or with reduced kidney function
- medical problems in participants with low blood pressure below <100 mmHg or with symptoms due to low blood pressure
- any medical problems after prolonged periods of treatment with vericiguat. These medical problems are also known as "adverse events" (AEs) which may or may not be related to the study treatment.
In addition, this study will gather information about how long vericiguat treatment can prevent death caused by cardiovascular problems such as heart attack and stroke compared to standard of care. Cardiovascular death (safety specification) will be assessed in a comparative manner with the control arm as the primary objective
The participants will receive their treatments as prescribed by their doctors according to the approved product information. The data for this study will be collected using an electronic case report form (eCRF) and medical records. The following data from the study participants will be documented during visits that take place in routine practice:
- underlying and concomitant diseases,
- prior medication,
- treatment duration,
- laboratory parameters,
- vital signs,
- results of cardiac exams (e.g. cardiac ultrasound),
- heart failure related hospitalization events,
- adverse events. The data collection will start from the beginning of vericiguat/standard of care treatment and will cover a time period of 2 years unless no further information can be expected from the participant at a given point in time, or death.
The total study duration will be six years, including data analysis and cleaning.
- Conditions
- Chronic Heart Failure
- Being tested
- Vericiguat (Verquvo, BAY1021189), Standard of care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vericiguat (Verquvo, BAY1021189)Drug
Dosage at the discretion of the treating physician, based on the recommendations written in the product information.
Standard of careDrug
Dosage at the discretion of the treating physician
| Study group | Role | What they receive |
|---|---|---|
| vericiguat arm | Japanese patients with a diagnosis of chronic heart failure who received standard treatment and will start vericiguat therapy for chronic heart failure. Receives: Drug: Vericiguat (Verquvo, BAY1021189) | |
| control arm | Japanese patients a diagnosis of chronic heart failure who received standard treatment and will continue standard of care treatment for chronic heart failure. Receives: Drug: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Adverse Events (AEs) for vericiguat arm
Measured: Up to 2 years.
Seriousness of Adverse Events (AEs) for vericiguat arm
Measured: Up to 2 years
Outcome of Adverse Events (AEs) for vericiguat arm
Measured: Up to 2 years
Causality assessment of Adverse Events (AEs) for vericiguat arm
Measured: Up to 2 years
Incidence of Cardiovascular (CV) death for vericiguat arm and control arm
Definition of CV death is Heart failure, acute myocardial infarction, stroke (cerebral infarction, cerebral hemorrhage), sudden death, other CV deaths (e.g., pulmonary embolism, peripheral arterial disease), death of unknown cause
Measured: Up to 2 years
Secondary outcomes (16)
The duration (days) of vericiguat treatment for vericiguat arm
Measured: Up to 2 years
The reason for ending vericiguat treatment/observation for vericiguat arm
Measured: Up to 2 years
Dosage and dose modification of vericiguat treatment for vericiguat arm
Measured: Up to 2 years
Systolic blood pressure and diastolic blood pressure for vericiguat arm
Measured: Up to 2 years
Pulse rate for vericiguat arm
Measured: Up to 2 years
Assessment of left ventricular end-diastolic volume index and left ventricular end-systolic volume index for vericiguat arm
Measured: Up to 2 years
Assessment of left ventricular ejection fraction for vericiguat arm
Measured: Up to 2 years
Assessment of Brain Natriuretic Peptide/N-terminal pro-Brain Natriuretic Peptide for vericiguat arm
Measured: Up to 2 years
Assessment of Serum creatinine for vericiguat arm
Measured: Up to 2 years
Assessment of e-GFR for vericiguat arm
Measured: Up to 2 years
Assessment of Hemoglobin for vericiguat arm
Measured: Up to 2 years
Assessment of Hematocrit for vericiguat arm
Measured: Up to 2 years
Assessment of New York Heart Association (NYHA) classification for vericiguat arm
Measured: Up to 2 years
Concomitant medications for vericiguat arm
Measured: Up to 2 years
All-cause mortality for vericiguat arm
Measured: Up to 2 years
Number of patients with Heart Failure (HF) hospitalization during observation period for vericiguat arm
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start31 Aug 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666518
- Sponsor's protocol ID
- 21880
- Status last verified
- Jul 2026
- First submitted
- 2 Dec 2022
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vericiguat Drug Use Two-arm Investigation in Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT05666518
- Acronym / sponsor ID
- 21880
- Conditions
- Chronic Heart Failure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 28 Dec 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.
This is an observational study in which data from Japanese people with chronic heart failure who will be receiving vericiguat is studied.
Chronic heart failure (HF) is a long-term condition where the heart does not pump blood as well as it should. Heart failure can lead to other serious medical conditions, and it can lead to hospitalization or death.
The drug vericiguat works by increasing the activity of an enzyme called soluble guanylate cyclase (sGC). The sGC enzyme helps regulate the heart and blood circulation. Vericiguat is already available and approved for doctors to prescribe to people who have heart failure. A limited number of patients have been treated with vericiguat. Therefore information about its safety in a broader population and especially among Japanese people as well as for prolonged periods of treatment is still missing.
In this study, the researchers want to learn more about how safe vericiguat is if used in Japanese people with long term HF. To see how safe vericiguat is, the researchers will collect the medical problems the participants have during the treatment with vericiguat under real-word conditions. They will particularly focus on the following:
- high blood pressure
- any medical problems due to combination of the study treatment vericiguat with nitrates and nitric oxide (NO) donors or with PDE5 inhibitors
- medical problems in participants with liver problems or with reduced kidney function
- medical problems in participants with low blood pressure below <100 mmHg or with symptoms due to low blood pressure
- any medical problems after prolonged periods of treatment with vericiguat. These medical problems are also known as "adverse events" (AEs) which may or may not be related to the study treatment.
In addition, this study will gather information about how long vericiguat treatment can prevent death caused by cardiovascular problems such as heart attack and stroke compared to standard of care. Cardiovascular death (safety specification) will be assessed in a comparative manner with the control arm as the primary objective
The participants will receive their treatments as prescribed by their doctors according to the approved product information. The data for this study will be collected using an electronic case report form (eCRF) and medical records. The following data from the study participants will be documented during visits that take place in routine practice:
- underlying and concomitant diseases,
- prior medication,
- treatment duration,
- laboratory parameters,
- vital signs,
- results of cardiac exams (e.g. cardiac ultrasound),
- heart failure related hospitalization events,
- adverse events. The data collection will start from the beginning of vericiguat/standard of care treatment and will cover a time period of 2 years unless no further information can be expected from the participant at a given point in time, or death.
The total study duration will be six years, including data analysis and cleaning.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vericiguat arm | – | Drug: Vericiguat (Verquvo, BAY1021189)Japanese patients with a diagnosis of chronic heart failure who received standard treatment and will start vericiguat therapy for chronic heart failure. |
| control arm | – | Drug: Standard of careJapanese patients a diagnosis of chronic heart failure who received standard treatment and will continue standard of care treatment for chronic heart failure. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population is composed of Japanese patients with chronic heart failure have been prescribed vericiguat or standard treatment by the physician.
Key inclusion criteria (9 listed)
- Patients receiving standard treatment for chronic heart failure, and vericiguat will be treated in accordance with the package insert (no history of receiving vericiguat)
- Patients who gave written consent to this investigation
- Patients receiving standard treatment for chronic heart failure according to the package insert of vericiguat as following (no history of receiving vericiguat)
- Patients who gave written informed consent to this study
Key exclusion criteria (5 listed)
- Patients who are participating in an interventional study
- Patients who have started or are scheduled to start therapy with vericiguat for chronic heart failure
- Patients who are participating in an interventional study
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 |
|---|---|---|
| Vericiguat (Verquvo, BAY1021189)Dosage at the discretion of the treating physician, based on the recommendations written in the product information. | Drug | vericiguat arm |
| Standard of careDosage at the discretion of the treating physician | Drug | control arm |
Primary outcome
Severity of Adverse Events (AEs) for vericiguat arm
Time frame: Up to 2 years.
Seriousness of Adverse Events (AEs) for vericiguat arm
Time frame: Up to 2 years
Outcome of Adverse Events (AEs) for vericiguat arm
Time frame: Up to 2 years
Causality assessment of Adverse Events (AEs) for vericiguat arm
Time frame: Up to 2 years
Incidence of Cardiovascular (CV) death for vericiguat arm and control arm
Time frame: Up to 2 years
Definition of CV death is Heart failure, acute myocardial infarction, stroke (cerebral infarction, cerebral hemorrhage), sudden death, other CV deaths (e.g., pulmonary embolism, peripheral arterial disease), death of unknown cause
16 secondary outcomes
The duration (days) of vericiguat treatment for vericiguat arm
Time frame: Up to 2 years
The reason for ending vericiguat treatment/observation for vericiguat arm
Time frame: Up to 2 years
Dosage and dose modification of vericiguat treatment for vericiguat arm
Time frame: Up to 2 years
Systolic blood pressure and diastolic blood pressure for vericiguat arm
Time frame: Up to 2 years
Pulse rate for vericiguat arm
Time frame: Up to 2 years
Assessment of left ventricular end-diastolic volume index and left ventricular end-systolic volume index for vericiguat arm
Time frame: Up to 2 years
Assessment of left ventricular ejection fraction for vericiguat arm
Time frame: Up to 2 years
Assessment of Brain Natriuretic Peptide/N-terminal pro-Brain Natriuretic Peptide for vericiguat arm
Time frame: Up to 2 years
Assessment of Serum creatinine for vericiguat arm
Time frame: Up to 2 years
Assessment of e-GFR for vericiguat arm
Time frame: Up to 2 years
Assessment of Hemoglobin for vericiguat arm
Time frame: Up to 2 years
Assessment of Hematocrit for vericiguat arm
Time frame: Up to 2 years
Assessment of New York Heart Association (NYHA) classification for vericiguat arm
Time frame: Up to 2 years
Concomitant medications for vericiguat arm
Time frame: Up to 2 years
All-cause mortality for vericiguat arm
Time frame: Up to 2 years
Number of patients with Heart Failure (HF) hospitalization during observation period for vericiguat arm
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- 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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Heart Failure, run by Bayer at 1 site in Japan.
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 9 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bayer Clinical Trials Contact ((+)1-888-84 22937, clinical-trials-contact@bayer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of Adverse Events (AEs) for vericiguat arm (time frame: Up to 2 years.). The study lists 5 primary outcomes in all. 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 6 Jul 2026.