Chronic Heart Failure With Reduced Ejection FractionVERI-ChinaNCT05728502
An Observational Study, Called VERI-China, to Learn More About How Well Vericiguat Works and How Safe it is in Real-world Setting in People With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) in China
An observational study of Chronic Heart Failure With Reduced Ejection Fraction, run by Bayer at 1 site in China.
Trial summary
This is an observational study in which data from people in China with chronic heart failure with reduced ejection fraction (HFrEF) who will be receiving vericiguat treatment are collected. Vericiguat treatment will be compared to available data on standard of care (SOC) treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure With Reduced Ejection Fraction
- What is being tested?
- Vericiguat (Verquvo, BAY1021189)
- How many people
- 2,400 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2023to 26 Dec 2025
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population is composed of Chinese adult HFrEF patients who are prescribed vericiguat or standard treatment by the physician.
Who may be able to join
- vericiguat arm
- Female and male patients ≥ 18 years of age who are naïve to vericiguat treatment
- Patients with HFrEF after a recent decompensation episode (within 6 months of heart failure hospitalization or within 3 months of intravenous (IV) diuretics for heart failure not requiring hospitalization)
- Decision to initiate treatment with vericiguat as per the local approved label
- Signed informed consent
- control arm
Show all 9Show fewer
- Aged 18 or over at baseline
- Only patients receiving SoC for chronic heart failure (no history of receiving vericiguat prior to the index date)
- Patients with HFrEF after a recent decompensation episode (within 6 months of heart failure hospitalization or within 3 months of intravenous (IV) diuretics for heart failure not requiring hospitalization)
Who cannot join
- vericiguat arm
- Participation in other investigational program with interventions outside of routine clinical practice
- Contra-indications according to the local marketing authorization label
- control arm
- Patients who have started therapy with vericiguat for chronic heart failure at baseline
- Contra-indications according to the vericiguat local marketing authorization label
- Patients participating in an interventional study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Two-arm, Open-label, Externally Controlled, Post-marketing Study of the Effectiveness and Safety of Vericiguat in HFrEF Patients in China
This is an observational study in which data from people in China with chronic heart failure with reduced ejection fraction (HFrEF) who will be receiving vericiguat treatment are collected. Vericiguat treatment will be compared to available data on standard of care (SOC) treatment. In observational studies, only observations are made without specified advice or interventions.
HFrEF is a long-term condition where the left side of the heart does not pump blood out to the body as well as it should. Blood and fluid may collect in the lungs, blood vessels, and tissues causing shortness of breath or tiredness. Over time, heart failure can lead to other serious medical conditions that may result in hospital stays and death.
Read more
The drug vericiguat works by increasing the activity of an enzyme called soluble guanylate cyclase (sGC). The sGC enzyme helps to regulate the heart and blood circulation. Vericiguat is already available in China and other countries for doctors to prescribe to people with heart failure. Vericiguat has already been studied in previous clinical studies. However, the data from these studies were restricted by inclusion and exclusion criteria. Therefore, this real-world study will collect important data from real-world setting in China.
The main purpose of this study is to collect more data on how well vericiguat works compared with current SOC in Chinese people with HFrEF under everyday conditions.
Working well means that the treatment can prevent the following from happening:
- death due to heart and circulatory events,
- a hospital stay due to heart conditions (failure).
In addition, the study team will gather more information about how safe the study drug vericiguat is for Chinese people with HFrEF. To do this, the researchers will collect all medical problems the participants have during the study. These medical problems are also known as "adverse events" and may or may not be related to the study treatment.
Subsequently, the study team will compare the data between participants who received the study drug vericiguat and those who received SOC. The SOC is the currently appropriate treatment in accordance with scientific evidence and agreed upon in collaboration between medical experts for HFrEF.
The participants will take vericiguat as prescribed by their doctors during routine practice according to the approved product information. For the vericiguat group, data will be collected at routine visits, which are not mandated by this study. The data for the comparison (SOC group) will come from a database called China Heart Failure Center. These data will be collected retrospectively for a comparable period of time.
The following data from the study participants will be documented during visits that take place in routine practice every 3 months:
- underlying and concomitant diseases,
- prior medication,
- laboratory parameters,
- vital signs such as blood pressure, heart rate,
- results of cardiac exams (e.g. echocardiography),
- information about how and in which amount vericiguat is usually given to patients.
The participants will be treated with vericiguat and followed up to 12 months or until they leave the study, whatever comes first.
- Being tested
- Vericiguat (Verquvo, BAY1021189), Standard of Care (SoC)
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 Care (SoC)Drug
Dosage at the discretion of the treating physician.
| Study group | Role | What they receive |
|---|---|---|
| vericiguat arm | Chinese adult patients with Heart Failure with Reduced Ejection Fraction (HFrEF) who are prescribed vericiguat under routine treatment conditions. Data will be prospectively collected. Receives: Drug: Vericiguat (Verquvo, BAY1021189) | |
| external control arm | Chinese adult HFrEF patients who received SoC treatment will be collected from China Heart Failure Center registry database. This control arm will be retrospectively collected from the patients in the database in the same period, from FPFV to LPFV of the vericiguat arm, and matched by propensity score based on baseline characteristics. Receives: Drug: Standard of Care (SoC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first occurrence of the composite of cardiovascular (CV) death or first hospitalization due to Heart Failure (HF)
Measured: Up to 1 year.
Secondary outcomes (5)
Time to first occurrence of CV death
Measured: Up to 1 year
Time to first occurrence of HF hospitalization
Measured: Up to 1 year
Time to first occurrence of the composite of death due to all causes or first HF hospitalization
Measured: Up to 1 year
Time to death due to all-causes
Measured: Up to 1 year
Occurrence of collected Adverse Event (AE) and Serious Adverse Event (SAE)
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start25 Apr 2023
- Primary completion29 Oct 2025
- Study completion26 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart Failure With Reduced Ejection FractionStudies 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
- Other
- Enrolment
- 2,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728502
- Sponsor's protocol ID
- 22323
- Acronym
- VERI-China
- Status last verified
- Jan 2026
- First submitted
- 6 Feb 2023
- Last updated
- 30 Jan 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.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 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Two-arm, Open-label, Externally Controlled, Post-marketing Study of the Effectiveness and Safety of Vericiguat in HFrEF Patients in China
- ClinicalTrials.gov ID
- NCT05728502
- Acronym / sponsor ID
- VERI-China / 22323
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,400 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 29 Oct 2025 (actual)
- Study completion
- 26 Dec 2025 (actual)
- First posted
- 15 Feb 2023 (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 people in China with chronic heart failure with reduced ejection fraction (HFrEF) who will be receiving vericiguat treatment are collected. Vericiguat treatment will be compared to available data on standard of care (SOC) treatment. In observational studies, only observations are made without specified advice or interventions.
HFrEF is a long-term condition where the left side of the heart does not pump blood out to the body as well as it should. Blood and fluid may collect in the lungs, blood vessels, and tissues causing shortness of breath or tiredness. Over time, heart failure can lead to other serious medical conditions that may result in hospital stays and death.
The drug vericiguat works by increasing the activity of an enzyme called soluble guanylate cyclase (sGC). The sGC enzyme helps to regulate the heart and blood circulation. Vericiguat is already available in China and other countries for doctors to prescribe to people with heart failure. Vericiguat has already been studied in previous clinical studies. However, the data from these studies were restricted by inclusion and exclusion criteria. Therefore, this real-world study will collect important data from real-world setting in China.
The main purpose of this study is to collect more data on how well vericiguat works compared with current SOC in Chinese people with HFrEF under everyday conditions.
Working well means that the treatment can prevent the following from happening:
- death due to heart and circulatory events,
- a hospital stay due to heart conditions (failure).
In addition, the study team will gather more information about how safe the study drug vericiguat is for Chinese people with HFrEF. To do this, the researchers will collect all medical problems the participants have during the study. These medical problems are also known as "adverse events" and may or may not be related to the study treatment.
Subsequently, the study team will compare the data between participants who received the study drug vericiguat and those who received SOC. The SOC is the currently appropriate treatment in accordance with scientific evidence and agreed upon in collaboration between medical experts for HFrEF.
The participants will take vericiguat as prescribed by their doctors during routine practice according to the approved product information. For the vericiguat group, data will be collected at routine visits, which are not mandated by this study. The data for the comparison (SOC group) will come from a database called China Heart Failure Center. These data will be collected retrospectively for a comparable period of time.
The following data from the study participants will be documented during visits that take place in routine practice every 3 months:
- underlying and concomitant diseases,
- prior medication,
- laboratory parameters,
- vital signs such as blood pressure, heart rate,
- results of cardiac exams (e.g. echocardiography),
- information about how and in which amount vericiguat is usually given to patients.
The participants will be treated with vericiguat and followed up to 12 months or until they leave the study, whatever comes first.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vericiguat arm | – | Drug: Vericiguat (Verquvo, BAY1021189)Chinese adult patients with Heart Failure with Reduced Ejection Fraction (HFrEF) who are prescribed vericiguat under routine treatment conditions. Data will be prospectively collected. |
| external control arm | – | Drug: Standard of Care (SoC)Chinese adult HFrEF patients who received SoC treatment will be collected from China Heart Failure Center registry database. This control arm will be retrospectively collected from the patients in the database in the same period, from FPFV to LPFV of the vericiguat arm, and matched by propensity score based on baseline characteristics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is composed of Chinese adult HFrEF patients who are prescribed vericiguat or standard treatment by the physician.
Key inclusion criteria (9 listed)
- vericiguat arm
- Female and male patients ≥ 18 years of age who are naïve to vericiguat treatment
- Patients with HFrEF after a recent decompensation episode (within 6 months of heart failure hospitalization or within 3 months of intravenous (IV) diuretics for heart failure not requiring hospitalization)
- Decision to initiate treatment with vericiguat as per the local approved label
- Signed informed consent
Key exclusion criteria (7 listed)
- vericiguat arm
- Participation in other investigational program with interventions outside of routine clinical practice
- Contra-indications according to the local marketing authorization label
- control arm
- Patients who have started therapy with vericiguat for chronic heart failure at baseline
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 Care (SoC)Dosage at the discretion of the treating physician. | Drug | external control arm |
Primary outcome
Time to first occurrence of the composite of cardiovascular (CV) death or first hospitalization due to Heart Failure (HF)
Time frame: Up to 1 year.
5 secondary outcomes
Time to first occurrence of CV death
Time frame: Up to 1 year
Time to first occurrence of HF hospitalization
Time frame: Up to 1 year
Time to first occurrence of the composite of death due to all causes or first HF hospitalization
Time frame: Up to 1 year
Time to death due to all-causes
Time frame: Up to 1 year
Occurrence of collected Adverse Event (AE) and Serious Adverse Event (SAE)
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 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.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.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 With Reduced Ejection Fraction, run by Bayer at 1 site in China.
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 7 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: finished, as of the sponsor's last update on 30 Jan 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to first occurrence of the composite of cardiovascular (CV) death or first hospitalization due to Heart Failure (HF) (time frame: Up to 1 year.). 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 30 Jan 2026.