Chronic Heart Failure With Reduced Ejection FractionNCT06148935
An Observational Study to Learn More About the Use of Vericiguat in Korean People With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) in Real-world Setting
An observational study of Chronic Heart Failure With Reduced Ejection Fraction, run by Bayer at 1 site in South Korea.
Trial summary
This is an observational study in which only data are collected from participants receiving their usual treatment. The study is done in people with chronic heart failure with reduced ejection fraction (HFrEF). HFrEF is a long-term condition in which the heart does not pump blood as well as it should. Read more about this study
- Who is it for?
- Ages 19 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
- 1,350 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Nov 2023to 31 Oct 2027
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Female and male participants with a diagnosis of heart failure with reduced ejection fraction (HFrEF) will be enrolled after the decision for treatment with Verquvo (Vericiguat) has been made by the investigator´s discretion.
Who may be able to join
- Adult aged 19 years or older
- Chronic HF (NYHA functional class II, III, or IV) Reduced left ventricular ejection fraction (< 45%) within 12 months before enrollment
- Worsening of heart failure (hospitalized within 6 months before enrollment or intravenous diuretic therapy without hospitalization within 3 months)
- Participants who have been prescribed Verquvo (Vericiguat) as per locally approved label and didn't receive Verquvo (Vericiguat) therapy previously.
- Written informed consent from subject or legal representative; assent from subject when appropriate
Who cannot join
- Contraindication according to the local authorized label (including known hypersensitivity to the drug substance or any of its components, pregnancy)
- Participants participating in an investigational program with interventions outside of routine clinical practice
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Many Locations
Multiple Locations
About this study
Official title: Post-marketing Surveillance Study for Verquvo (Vericiguat) in Korean Heart Failure Patients With Reduced Ejection Fraction
This is an observational study in which only data are collected from participants receiving their usual treatment. The study is done in people with chronic heart failure with reduced ejection fraction (HFrEF). HFrEF is a long-term condition in which the heart does not pump blood 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 study treatment vericiguat works by increasing the activity of an enzyme called soluble guanylate cyclase (sGC). sGC helps to regulate the heart and blood circulation. Vericiguat has already been studied in previous clinical studies and is available for doctors to prescribe to people with heart failure. This study will collect important data from real-world setting in Korea. The participants of this study are people with HFrEF who will receive vericiguat as prescribed by their doctors according to the approved product information
Read more
The main purpose of this study is to learn more about how safe vericiguat is in the participants. To do this, researchers will collect data on all medical problems (also called adverse events) that the participants have during the study. Doctors keep track of all adverse events, even if they do not think they might be related to the study treatment.
Further, researchers will collect data on how well vericiguat works and treatment patterns in the participants. For this, the following information will be collected:
- occurrence of death due to heart and circulatory events
- hospital stays due to heart conditions (failure)
- dose levels of vericiguat and duration of treatment
The data for this study will come from medical records and visits that take place in routine practice. Participants will be treated with vericiguat and observed up to 12 months or until death or they leave the study, whatever comes first.
- Being tested
- Vericiguat (Verquvo, BAY1021189)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vericiguat (Verquvo, BAY1021189)Drug
Following the manner of observational study, no intervention will be provided in the study. Participants follow locally approved label, without interference by the study initiator or study protocol
| Study group | Role | What they receive |
|---|---|---|
| Korean adult participants with HFrEF | Korean heart failure participants with reduced ejection fraction (HFrEF) who are prescribed Verquvo (Vericiguat) for an approved indication by the Ministry of Food and Drug Safety (MFDS) in Korea Receives: Drug: Vericiguat (Verquvo, BAY1021189) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs), serious adverse events (SAEs), adverse drug reactions (ADRs), serious adverse drug reactions (SADRs), unexpected adverse events (unexpected AEs) and unexpected adverse drug reactions (unexpected ADRs)
Measured: From the date first administration of Verquvo (Vericiguat) to 14 days after the end of the treatment period, up to 12 months for each participant.
Secondary outcomes (5)
Occurrence of the composite of cardiovascular (CV) death or first hospitalization due to heart failure (HF)
Measured: From initial visit to final visit, up to 12 months for each participant
Occurrence of CV death
Measured: From initial visit to final visit, up to 12 months for each participant
Occurrence of HF hospitalization
Measured: From initial visit to final visit, up to 12 months for each participant
Time to reach different dose levels of Verquvo (Vericiguat) during initial titration
Measured: From initial visit to final visit, up to 12 months for each participant
Relative time on different dose levels of Verquvo (Vericiguat) during follow-up
Measured: From first follow-up visit to final visit, up to 11 months for each participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start30 Nov 2023
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
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
- Prospective
- Enrolment
- 1,350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148935
- Sponsor's protocol ID
- 22013
- Status last verified
- Jul 2026
- First submitted
- 20 Nov 2023
- 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.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 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-marketing Surveillance Study for Verquvo (Vericiguat) in Korean Heart Failure Patients With Reduced Ejection Fraction
- ClinicalTrials.gov ID
- NCT06148935
- Acronym / sponsor ID
- 22013
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,350 participants (estimated)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 28 Nov 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 only data are collected from participants receiving their usual treatment. The study is done in people with chronic heart failure with reduced ejection fraction (HFrEF). HFrEF is a long-term condition in which the heart does not pump blood 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 study treatment vericiguat works by increasing the activity of an enzyme called soluble guanylate cyclase (sGC). sGC helps to regulate the heart and blood circulation. Vericiguat has already been studied in previous clinical studies and is available for doctors to prescribe to people with heart failure. This study will collect important data from real-world setting in Korea. The participants of this study are people with HFrEF who will receive vericiguat as prescribed by their doctors according to the approved product information
The main purpose of this study is to learn more about how safe vericiguat is in the participants. To do this, researchers will collect data on all medical problems (also called adverse events) that the participants have during the study. Doctors keep track of all adverse events, even if they do not think they might be related to the study treatment.
Further, researchers will collect data on how well vericiguat works and treatment patterns in the participants. For this, the following information will be collected:
- occurrence of death due to heart and circulatory events
- hospital stays due to heart conditions (failure)
- dose levels of vericiguat and duration of treatment
The data for this study will come from medical records and visits that take place in routine practice. Participants will be treated with vericiguat and observed up to 12 months or until death or they leave the study, whatever comes first.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Korean adult participants with HFrEF | – | Drug: Vericiguat (Verquvo, BAY1021189)Korean heart failure participants with reduced ejection fraction (HFrEF) who are prescribed Verquvo (Vericiguat) for an approved indication by the Ministry of Food and Drug Safety (MFDS) in Korea |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female and male participants with a diagnosis of heart failure with reduced ejection fraction (HFrEF) will be enrolled after the decision for treatment with Verquvo (Vericiguat) has been made by the investigator´s discretion.
Key inclusion criteria (5 listed)
- Adult aged 19 years or older
- Chronic HF (NYHA functional class II, III, or IV) Reduced left ventricular ejection fraction (< 45%) within 12 months before enrollment
- Worsening of heart failure (hospitalized within 6 months before enrollment or intravenous diuretic therapy without hospitalization within 3 months)
- Participants who have been prescribed Verquvo (Vericiguat) as per locally approved label and didn't receive Verquvo (Vericiguat) therapy previously.
- Written informed consent from subject or legal representative; assent from subject when appropriate
Key exclusion criteria (2 listed)
- Contraindication according to the local authorized label (including known hypersensitivity to the drug substance or any of its components, pregnancy)
- Participants participating in an investigational program with interventions outside of routine clinical practice
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)Following the manner of observational study, no intervention will be provided in the study. Participants follow locally approved label, without interference by the study initiator or study protocol | Drug | Korean adult participants with HFrEF |
Primary outcome
Number of participants with adverse events (AEs), serious adverse events (SAEs), adverse drug reactions (ADRs), serious adverse drug reactions (SADRs), unexpected adverse events (unexpected AEs) and unexpected adverse drug reactions (unexpected ADRs)
Time frame: From the date first administration of Verquvo (Vericiguat) to 14 days after the end of the treatment period, up to 12 months for each participant.
5 secondary outcomes
Occurrence of the composite of cardiovascular (CV) death or first hospitalization due to heart failure (HF)
Time frame: From initial visit to final visit, up to 12 months for each participant
Occurrence of CV death
Time frame: From initial visit to final visit, up to 12 months for each participant
Occurrence of HF hospitalization
Time frame: From initial visit to final visit, up to 12 months for each participant
Time to reach different dose levels of Verquvo (Vericiguat) during initial titration
Time frame: From initial visit to final visit, up to 12 months for each participant
Relative time on different dose levels of Verquvo (Vericiguat) during follow-up
Time frame: From first follow-up visit to final visit, up to 11 months for each participant
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.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.
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 South Korea.
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 5 inclusion and 2 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 South Korea. 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?
Number of participants with adverse events (AEs), serious adverse events (SAEs), adverse drug reactions (ADRs), serious adverse drug reactions (SADRs), unexpected adverse events (unexpected AEs) and unexpected adverse drug reactions (unexpected ADRs) (time frame: From the date first administration of Verquvo (Vericiguat) to 14 days after the end of the treatment period, up to 12 months for each participant.). 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.