Chronic Heart FailureROVER JapanNCT06697353
An Observational Study to Learn More About the Real-world Outcomes in Patients With Heart Failure Who Initiate Treatment With Vericiguat in Japan
An observational study of Chronic Heart Failure and Chronic Heart Failure With Reduced Ejection Fraction, run by Bayer at 1 site in Japan.
Trial summary
This is an observational study in which data already collected from people with chronic heart failure is studied. Chronic 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure, Chronic Heart Failure With Reduced Ejection Fraction
- What is being tested?
- vericiguat (BAY 1021189)
- Type of treatment
- Injection or infusion
- How many people
- 4,936 participants
- Where
- 1 siteJapan
- Study dates
- 1 Nov 2024to 19 Sep 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 adult patients with HF diagnosis code between March 2021 and July 2024, initiating vericiguat between September 2021 and July 2024, with HF diagnosis prior to index date, and with at least 180 days of observation prior to index date.
Who may be able to join
- Patients who initiate vericiguat (identified by Anatomical Therapeutic Chemical [ATC] code C01DX22, generic name and receipt code [to be defined in the SAP]) between September 2021 and July 2024
- Patients who have diagnosis code of HF (identified by World Health Organization [WHO] International Classification of Diseases, 10th revision [ICD-10] codes I50, I11.0) prior to index date
- Patients aged 18 years or older at index date
Who cannot join
- Patients with observability for less than 180 days prior to index date
- Patients with a follow-up period of 0 days.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ROVER Japan/ Real-world Outcomes of Patients Treated With Vericiguat in Japanese Routine Care: a Retrospective Cohort Study Using a Hospital Administrative Database
This is an observational study in which data already collected from people with chronic heart failure is studied.
Chronic 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 or even death.
Read more
The study drug, vericiguat, is already approved for doctors to prescribe to people with chronic HFrEF in Japan.
Vericiguat increases the activity of an enzyme called soluble guanylate cyclase (sGC), which relaxes the blood vessels, allowing more blood to flow through. As a result, the heart is able to pump better.
The participants in this study are already receiving treatment with vericiguat (newly initiated) as part of their regular care from their doctors.
There is currently limited real-world data on the use of vericiguat in Japanese people. Therefore, more research is needed on larger groups of Japanese people for a longer period to understand the effects of use of vericiguat.
The main purpose of this study is to collect information about how well vericiguat is used in Japanese people with heart failure who initiate vericiguat treatment.
To do this, researchers will collect the following information for participants who newly initiated vericiguat:
occurrence of death due to heart and blood vessel related events
occurrence of death due to any reason
hospital stays due to heart failure
a combination of hospital stays due to heart failure or occurrence of death due to heart and blood-vessel related events
a combination of occurrence of death due to any reason or hospital stays due to heart failure
In addition, researchers will collect the following information:
participants' characteristics, including age, sex, height, weight, and medical history
how well did the participants follow their prescribed treatment with vericiguat over the year after starting it
how long did the participants continue to take vericiguat over the year after starting it
changes in the dose of vericiguat in the participants over the year after starting it
other treatment options participants have taken for the treatment of heart failure
changes in laboratory values and other test results before and after treatment with vericiguat
The data will come from the participants' hospital records provided by the Medical Data Vision Co., Ltd. They will cover the period from September 2016 to July 2024.
Researchers will track participants' data and will follow them for a maximum of one year after starting treatment with vericiguat, or until any of the following happens:
the participant dies
the participant cannot be tracked anymore
the end of the study
In this study, only available data from routine care are collected. No visits or tests are required as part of this study.
- Being tested
- vericiguat (BAY 1021189)
- Keywords
- HFrEF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vericiguat (BAY 1021189)Drug
Also called VERQUVO
2.5 mg initiating dose
| Study group | Role | What they receive |
|---|---|---|
| Study Cohort | Patients who initiated on-label use of vericiguat (i.e. patients treated with at least one HF therapy who initiated vericiguat with a starting dose of 2.5 mg). Adult patients with Heart Failure (HF) diagnosis code between March 2021 and July 2024, initiating vericiguat between September 2021 and July 2024, with HF diagnosis prior to index date, and with at least 180 days of observation prior to index date. Receives: Drug: vericiguat (BAY 1021189) | |
| Sub-Cohort a | derived from the study cohort, and defined as: With (a1) /without (a2) recent worsening of HF (WHF). With recent WHF will be defined as HF hospitalization within 6 months or outpatient intravenous diuretic dispensation (Anatomical Therapeutic Chemical (Classification System) (ATC) codes C03 and receipt code) within 3 months.
Without recent WHF will be defined as no HF hospitalization for 6 months and no outpatient Intravenous (IV) diuretic use for 3 months Receives: Drug: vericiguat (BAY 1021189) | |
| Sub-Cohort b | derived from the study cohort, and defined as: Time from WHF event to vericiguat initiation. Within patients with recent WHF, patients will further be classified according to the timing from WHF event as: HF hospitalization in the previous 3 months, HF hospitalization in the previous 3-6 months, and outpatient IV diuretics (without HF hospitalization) in the previous 3 months.
Note that patients who have a record of hospitalization both in the previous 3 months and the previous 3-6 months will be classified in "HF hospitalization in the previous 3-6 months. Receives: Drug: vericiguat (BAY 1021189) | |
| Sub-Cohort c | derived from the study cohort, and defined as: With (c1)/without (c2) Angiotensin Receptor Neprilysin Inhibitor (ARNI). With ARNI will be defined as presence of prescription or dispensation of sacubitril/valsartan (ATC code C09DX04), within the 90 days prior to index date (exclusive).
Without ARNI will be defined as absence of prescription or dispensation of sacubitril/valsartan (ATC code C09DX04), within the 90 days prior to index date (exclusive). Receives: Drug: vericiguat (BAY 1021189) | |
| Sub-Cohort d | derived from the study cohort, and defined as: With (d1)/without SGLT2i (d2). With SGLT2i will be defined as presence of prescription or dispensation of dapagliflozin (ATC code A10BK01) and empagliflozin (ATC code A10BK03) within the 90 days prior to index date (exclusive).
Without SGLT2i will be defined as absence of prescription or dispensation of dapagliflozin (ATC code A10BK01) and empagliflozin (ATC code A10BK03) within the 90 days prior to index date (exclusive). Receives: Drug: vericiguat (BAY 1021189) | |
| Sub-Cohort e | derived from the study cohort, and defined as: Number of foundational therapies (i.e., ACEi, ARB, ARNI, ACEi/ARB, ACEi/ARB/ARNI, BB, MRA and SGLT2i). Presence/absence of each foundational therapy - ACEi (enalapril [ATC code C09AA02] and lisinopril [ATC code C09AA03]), ARB (candesartan [ATC code C09CA06]), ARNI (sacubitril-valsartan [ATC code C09DX04]), ACEi/ARB, ACEi/ARB/ARNI, BB (bisoprolol [ATC code C07AB07] and carvedilol [ATC code C07AG02]), MRA (spironolactone [ATC code C03DA01] and eplerenone [ATC code C03DA04]) and SGLT2i (dapagliflozin [ATC code A10BK01] and empagliflozin [ATC code A10BK03]) - will be assessed within the 90 days prior to index date (exclusive).
The number of foundational therapies present will be categorized by none, mono therapy, dual therapy, triple therapy, and quadruple therapy. Receives: Drug: vericiguat (BAY 1021189) | |
| Sub-Cohort f | derived from the study cohort and defined as: Age group. Age group will be categorized as <65, 65 to <75, and ≥75 years Receives: Drug: vericiguat (BAY 1021189) | |
| Sub-Cohort g | derived from the study cohort, and defined as: sex (will be categorized as male and female) Receives: Drug: vericiguat (BAY 1021189) | |
| Sub-Cohort h | derived from study cohort and described as: Body mass index categories. Body mass index is defined as a person's weight in kilograms divided by the square of the person's height in meters (kg/m2), and will be categorized as underweight (<18.5 kg/m2), normal weight (18.5-24.9 kg/m2), pre-obesity (25.0-29.9 kg/m2), and obesity (≥30.0 kg/m2).
The body mass index value closest to the index date and prior to the index date will be used for this classification. If multiple body mass index values exist, the value closest to the index date will be used. Receives: Drug: vericiguat (BAY 1021189) | |
| Sub-Cohort i | derived from study cohort and described as: With chronic kidney disease (all; stage ≥3). With chronic kidney disease (CKD) will be defined by the presence of the N18 International Classification of Diseases, 10th revision (ICD-10 code( within 180 days prior to index date . A subset of CKD stage ≥3 will be identified with the N18.3-N18.5 ICD-10 codes. Receives: Drug: vericiguat (BAY 1021189) | |
| Sub-Cohort j | derived from study cohort and described as: Up-titration level of vericiguat at 3 months. Up-titration level for vericiguat at 3 months of treatment will be categorized as vericiguat dosage: 2.5 mg, 5 mg, 10 mg or other dose.
Note that when patients' up-titration level has increased to the upper level within 3 months, unless the level at 3 month remains at the upper level, the patients will not be considered up-titrated. Receives: Drug: vericiguat (BAY 1021189) | |
| Sub-Cohort k | derived from study cohort and described as: Adherent (k1) vs. non-adherent (k2) to vericiguat within 3 months. Adherence to vericiguat within 3 months of treatment will be defined as a medication possession ratio (MPR) of ≥80%.
Non-adherent to vericiguat within 3 months of treatment will be defined as MPR<80% . Receives: Drug: vericiguat (BAY 1021189) | |
| Sub-Cohort l | derived from study cohort and described as: Persistent (l1) vs. non-persistent (l2) to vericiguat within 3 months. Treatment discontinuation within 3 months of treatment will be identified by a gap of >30 days between successive prescription records or between the last prescription record and the end of follow-up. Persistent within 3 months will be defined as no treatment discontinuation within 3 months of treatment.
Non-persistent within 3 months to vericiguat will be defined as treatment discontinuation within 3 months of treatment. Receives: Drug: vericiguat (BAY 1021189) | |
| Sub Cohort m | derived from study cohort and described as: Index date categories. Patients will be classified according to the year of inclusion as follows: September 2021 to August 2022 vs. September 2022 to July 2024. Receives: Drug: vericiguat (BAY 1021189) | |
| Sub Cohort n | derived from the study cohort and described as: Discontinuing ARNI before initiating vericiguat. Patients with a prescription/dispensation of ARNI within the 90 days prior to index date (exclusive) and no prescription/dispensation of ARNI within the 90 days after the index date (inclusive). Receives: Drug: vericiguat (BAY 1021189) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rates of clinical outcomes in patients who initiate vericiguat
To estimate the incidence rates of cardiovascular death, all-cause death, HF hospitalization, a composite of cardiovascular death or HF hospitalization, and a composite of all-cause death or HF hospitalization in patients who initiate vericiguat
Measured: Retrospective analysis from September 2016 to July 2024; Up to one year after vericiguat initiation
Secondary outcomes (22)
characteristics of patients who initiate vericiguat: age
Age in years: to document the age range of patients initiating vericiguat
Measured: Baseline
characteristics of patients who initiate vericiguat: gender
Gender: to document the gender distribution of patients initiating vericiguat
Measured: Baseline
characteristics of patients who initiate vericiguat: BMI
BMI (in kg/m2) at baseline - To describe the weight distribution of patients who initiate vericiguat
Measured: Baseline
characteristics of patients who initiate vericiguat: recent Worsening Heart failure (WHF)
Documentation of Recent WHF event: HF hospitalization within 6 months or outpatient IV diuretics within 3 months prior to index date.
Measured: Baseline
characteristics of patients who initiate vericiguat, prior WHF
Prior WHF: HF hospitalization or outpatient IV diuretics with no specified evaluation period
Measured: Baseline
characteristics of patients who initiate vericiguat: Dialysis
Document the number of patients on maintenance dialysis
Measured: Baseline
characteristics of patients who initiate vericiguat: Time from recent WHF event
Treatment location after recent WHF event: HF hospitalization in the previous 3 months, HF hospitalization in the previous 3-6 months, and outpatient IV diuretics in the previous 3 months
Measured: Baseline
characteristics of patients who initiate vericiguat: Comorbidities
Document Comorbidities at baseline
Measured: Baseline
characteristics of patients who initiate vericiguat: setting
Setting of vericiguat initiation: inpatient or outpatient setting - To describe the characteristics of patients who initiate vericiguat
Measured: Baseline
characteristics of patients who initiate vericiguat: cardiovascular procedure
Document Cardiovascular procedures
Measured: Baseline
characteristics of patients who initiate vericiguat: HF foundational therapy, prior index date
HF foundational therapy within 90 days prior to index date
Measured: Baseline
characteristics of patients who initiate vericiguat: Number of HF foundational therapy
Number of HF foundational therapy within 90 days prior to index date
Measured: Baseline
adherence of vericiguat therapy for 1 year after treatment initiation: medication possession ratio (MPR)
To describe the adherence of vericiguat therapy for 1 year after treatment initiation measured by medication possession ratio (MPR)
Measured: 1 year (after vericiguat initiation)
adherence of vericiguat therapy for 1 year after treatment initiation: proportion of days covered (PDC)
To describe the adherence of vericiguat therapy for 1 year after treatment initiation measured by proportion of days covered (PDC)
Measured: 1 year (after vericiguat initiation)
persistence of vericiguat therapy for 1 year after treatment initiation: Duration of continuous treatment over the first year after the index date
To describe the persistence of vericiguat therapy for 1 year after treatment initiation measured by the duration of continuous treatment
Measured: 1 year (after vericiguat initiation)
persistence of vericiguat therapy for 1 year after treatment initiation: percentage of patients with continuous treatment at Day 365
To describe the persistence of vericiguat therapy for 1 year after treatment initiation measured by the percentage of patients with continuous treatment at Day 365
Measured: 1 year (after vericiguat initiation)
Pattern description of dose titration of vericiguat over 1 year after treatment initiation: Day-to-day patterns of vericiguat
To describe the patterns of dose titration of vericiguat over 1 year after treatment initiation measured by day-to-day patterns
Measured: 1 year (after vericiguat initiation)
Pattern description of dose titration of vericiguat over 1 year after treatment initiation: Time to up-titration of vericiguat from index date to Day 365
To describe the patterns of dose titration of vericiguat over 1 year after treatment initiation measured by time to up-titration
Measured: 1 year (after vericiguat initiation)
Pattern description of dose titration of vericiguat over 1 year after treatment initiation: Time to up-titration to maximal daily dose of vericiguat from index date to Day 365
To describe the patterns of dose titration of vericiguat over 1 year after treatment initiation measured by time to up-titration to maximal daily dose
Measured: 1 year (after vericiguat initiation)
Pattern description of Heart Failure (HF) therapy before and after vericiguat initiation
To describe the patterns of HF therapy before and after vericiguat initiation
Measured: Baseline and 1 year (after vericiguat initiation)
Pattern description of dose titration of HF therapy before and after vericiguat initiation
To describe the patterns of dose titration of HF therapy before and after vericiguat initiation
Measured: Baseline and 1 year after vericiguat initiation
assess the change in laboratory and clinical parameters before and after vericiguat initiation
To assess the change in laboratory and clinical parameters before and after vericiguat initiation measured by SBP, LVEF, NYHA classification, NT-proBNP, BNP, eGFR, hemoglobin, number of HF hospitalization per patient, dose of diuretics, and number and percentage of patients with diuretic use.
Measured: Baseline and 180 days after vericiguat initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start1 Nov 2024
- Primary completion19 Sep 2025
- Study completion19 Sep 2025
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
- Retrospective
- Enrolment
- 4,936 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06697353
- Sponsor's protocol ID
- 22849
- Acronym
- ROVER Japan
- Status last verified
- Oct 2025
- First submitted
- 31 Oct 2024
- Last updated
- 8 Oct 2025
- 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 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROVER Japan/ Real-world Outcomes of Patients Treated With Vericiguat in Japanese Routine Care: a Retrospective Cohort Study Using a Hospital Administrative Database
- ClinicalTrials.gov ID
- NCT06697353
- Acronym / sponsor ID
- ROVER Japan / 22849
- Keywords
- HFrEF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,936 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 19 Sep 2025 (actual)
- Study completion
- 19 Sep 2025 (actual)
- First posted
- 20 Nov 2024 (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 already collected from people with chronic heart failure is studied.
Chronic 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 or even death.
The study drug, vericiguat, is already approved for doctors to prescribe to people with chronic HFrEF in Japan.
Vericiguat increases the activity of an enzyme called soluble guanylate cyclase (sGC), which relaxes the blood vessels, allowing more blood to flow through. As a result, the heart is able to pump better.
The participants in this study are already receiving treatment with vericiguat (newly initiated) as part of their regular care from their doctors.
There is currently limited real-world data on the use of vericiguat in Japanese people. Therefore, more research is needed on larger groups of Japanese people for a longer period to understand the effects of use of vericiguat.
The main purpose of this study is to collect information about how well vericiguat is used in Japanese people with heart failure who initiate vericiguat treatment.
To do this, researchers will collect the following information for participants who newly initiated vericiguat:
occurrence of death due to heart and blood vessel related events
occurrence of death due to any reason
hospital stays due to heart failure
a combination of hospital stays due to heart failure or occurrence of death due to heart and blood-vessel related events
a combination of occurrence of death due to any reason or hospital stays due to heart failure
In addition, researchers will collect the following information:
participants' characteristics, including age, sex, height, weight, and medical history
how well did the participants follow their prescribed treatment with vericiguat over the year after starting it
how long did the participants continue to take vericiguat over the year after starting it
changes in the dose of vericiguat in the participants over the year after starting it
other treatment options participants have taken for the treatment of heart failure
changes in laboratory values and other test results before and after treatment with vericiguat
The data will come from the participants' hospital records provided by the Medical Data Vision Co., Ltd. They will cover the period from September 2016 to July 2024.
Researchers will track participants' data and will follow them for a maximum of one year after starting treatment with vericiguat, or until any of the following happens:
the participant dies
the participant cannot be tracked anymore
the end of the study
In this study, only available data from routine care are collected. No visits or tests are required as part of this study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 15
| Arm | Type | Receives |
|---|---|---|
| Study Cohort | – | Drug: vericiguat (BAY 1021189)Patients who initiated on-label use of vericiguat (i.e. patients treated with at least one HF therapy who initiated vericiguat with a starting dose of 2.5 mg). Adult patients with Heart Failure (HF) diagnosis code between March 2021 and July 2024, initiating vericiguat between September 2021 and July 2024, with HF diagnosis prior to index date, and with at least 180 days of observation prior to index date. |
| Sub-Cohort a | – | Drug: vericiguat (BAY 1021189)derived from the study cohort, and defined as: With (a1) /without (a2) recent worsening of HF (WHF). With recent WHF will be defined as HF hospitalization within 6 months or outpatient intravenous diuretic dispensation (Anatomical Therapeutic Chemical (Classification System) (ATC) codes C03 and receipt code) within 3 months. Without recent WHF will be defined as no HF hospitalization for 6 months and no outpatient Intravenous (IV) diuretic use for 3 months |
| Sub-Cohort b | – | Drug: vericiguat (BAY 1021189)derived from the study cohort, and defined as: Time from WHF event to vericiguat initiation. Within patients with recent WHF, patients will further be classified according to the timing from WHF event as: HF hospitalization in the previous 3 months, HF hospitalization in the previous 3-6 months, and outpatient IV diuretics (without HF hospitalization) in the previous 3 months. Note that patients who have a record of hospitalization both in the previous 3 months and the previous 3-6 months will be classified in "HF hospitalization in the previous 3-6 months. |
| Sub-Cohort c | – | Drug: vericiguat (BAY 1021189)derived from the study cohort, and defined as: With (c1)/without (c2) Angiotensin Receptor Neprilysin Inhibitor (ARNI). With ARNI will be defined as presence of prescription or dispensation of sacubitril/valsartan (ATC code C09DX04), within the 90 days prior to index date (exclusive). Without ARNI will be defined as absence of prescription or dispensation of sacubitril/valsartan (ATC code C09DX04), within the 90 days prior to index date (exclusive). |
| Sub-Cohort d | – | Drug: vericiguat (BAY 1021189)derived from the study cohort, and defined as: With (d1)/without SGLT2i (d2). With SGLT2i will be defined as presence of prescription or dispensation of dapagliflozin (ATC code A10BK01) and empagliflozin (ATC code A10BK03) within the 90 days prior to index date (exclusive). Without SGLT2i will be defined as absence of prescription or dispensation of dapagliflozin (ATC code A10BK01) and empagliflozin (ATC code A10BK03) within the 90 days prior to index date (exclusive). |
| Sub-Cohort e | – | Drug: vericiguat (BAY 1021189)derived from the study cohort, and defined as: Number of foundational therapies (i.e., ACEi, ARB, ARNI, ACEi/ARB, ACEi/ARB/ARNI, BB, MRA and SGLT2i). Presence/absence of each foundational therapy - ACEi (enalapril [ATC code C09AA02] and lisinopril [ATC code C09AA03]), ARB (candesartan [ATC code C09CA06]), ARNI (sacubitril-valsartan [ATC code C09DX04]), ACEi/ARB, ACEi/ARB/ARNI, BB (bisoprolol [ATC code C07AB07] and carvedilol [ATC code C07AG02]), MRA (spironolactone [ATC code C03DA01] and eplerenone [ATC code C03DA04]) and SGLT2i (dapagliflozin [ATC code A10BK01] and empagliflozin [ATC code A10BK03]) - will be assessed within the 90 days prior to index date (exclusive). The number of foundational therapies present will be categorized by none, mono therapy, dual therapy, triple therapy, and quadruple therapy. |
| Sub-Cohort f | – | Drug: vericiguat (BAY 1021189)derived from the study cohort and defined as: Age group. Age group will be categorized as <65, 65 to <75, and ≥75 years |
| Sub-Cohort g | – | Drug: vericiguat (BAY 1021189)derived from the study cohort, and defined as: sex (will be categorized as male and female) |
| Sub-Cohort h | – | Drug: vericiguat (BAY 1021189)derived from study cohort and described as: Body mass index categories. Body mass index is defined as a person's weight in kilograms divided by the square of the person's height in meters (kg/m2), and will be categorized as underweight (<18.5 kg/m2), normal weight (18.5-24.9 kg/m2), pre-obesity (25.0-29.9 kg/m2), and obesity (≥30.0 kg/m2). The body mass index value closest to the index date and prior to the index date will be used for this classification. If multiple body mass index values exist, the value closest to the index date will be used. |
| Sub-Cohort i | – | Drug: vericiguat (BAY 1021189)derived from study cohort and described as: With chronic kidney disease (all; stage ≥3). With chronic kidney disease (CKD) will be defined by the presence of the N18 International Classification of Diseases, 10th revision (ICD-10 code( within 180 days prior to index date . A subset of CKD stage ≥3 will be identified with the N18.3-N18.5 ICD-10 codes. |
| Sub-Cohort j | – | Drug: vericiguat (BAY 1021189)derived from study cohort and described as: Up-titration level of vericiguat at 3 months. Up-titration level for vericiguat at 3 months of treatment will be categorized as vericiguat dosage: 2.5 mg, 5 mg, 10 mg or other dose. Note that when patients' up-titration level has increased to the upper level within 3 months, unless the level at 3 month remains at the upper level, the patients will not be considered up-titrated. |
| Sub-Cohort k | – | Drug: vericiguat (BAY 1021189)derived from study cohort and described as: Adherent (k1) vs. non-adherent (k2) to vericiguat within 3 months. Adherence to vericiguat within 3 months of treatment will be defined as a medication possession ratio (MPR) of ≥80%. Non-adherent to vericiguat within 3 months of treatment will be defined as MPR<80% . |
| Sub-Cohort l | – | Drug: vericiguat (BAY 1021189)derived from study cohort and described as: Persistent (l1) vs. non-persistent (l2) to vericiguat within 3 months. Treatment discontinuation within 3 months of treatment will be identified by a gap of >30 days between successive prescription records or between the last prescription record and the end of follow-up. Persistent within 3 months will be defined as no treatment discontinuation within 3 months of treatment. Non-persistent within 3 months to vericiguat will be defined as treatment discontinuation within 3 months of treatment. |
| Sub Cohort m | – | Drug: vericiguat (BAY 1021189)derived from study cohort and described as: Index date categories. Patients will be classified according to the year of inclusion as follows: September 2021 to August 2022 vs. September 2022 to July 2024. |
| Sub Cohort n | – | Drug: vericiguat (BAY 1021189)derived from the study cohort and described as: Discontinuing ARNI before initiating vericiguat. Patients with a prescription/dispensation of ARNI within the 90 days prior to index date (exclusive) and no prescription/dispensation of ARNI within the 90 days after the index date (inclusive). |
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 adult patients with HF diagnosis code between March 2021 and July 2024, initiating vericiguat between September 2021 and July 2024, with HF diagnosis prior to index date, and with at least 180 days of observation prior to index date.
Key inclusion criteria (3 listed)
- Patients who initiate vericiguat (identified by Anatomical Therapeutic Chemical [ATC] code C01DX22, generic name and receipt code [to be defined in the SAP]) between September 2021 and July 2024
- Patients who have diagnosis code of HF (identified by World Health Organization [WHO] International Classification of Diseases, 10th revision [ICD-10] codes I50, I11.0) prior to index date
- Patients aged 18 years or older at index date
Key exclusion criteria (2 listed)
- Patients with observability for less than 180 days prior to index date
- Patients with a follow-up period of 0 days.
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 (BAY 1021189)Also: VERQUVO2.5 mg initiating dose | Drug | Study Cohort, Sub Cohort m, Sub Cohort n, Sub-Cohort a, Sub-Cohort b, Sub-Cohort c, Sub-Cohort d, Sub-Cohort e, Sub-Cohort f, Sub-Cohort g, Sub-Cohort h, Sub-Cohort i, Sub-Cohort j, Sub-Cohort k, Sub-Cohort l |
Primary outcome
Incidence rates of clinical outcomes in patients who initiate vericiguat
Time frame: Retrospective analysis from September 2016 to July 2024; Up to one year after vericiguat initiation
To estimate the incidence rates of cardiovascular death, all-cause death, HF hospitalization, a composite of cardiovascular death or HF hospitalization, and a composite of all-cause death or HF hospitalization in patients who initiate vericiguat
22 secondary outcomes
characteristics of patients who initiate vericiguat: age
Time frame: Baseline
characteristics of patients who initiate vericiguat: gender
Time frame: Baseline
characteristics of patients who initiate vericiguat: BMI
Time frame: Baseline
characteristics of patients who initiate vericiguat: recent Worsening Heart failure (WHF)
Time frame: Baseline
characteristics of patients who initiate vericiguat, prior WHF
Time frame: Baseline
characteristics of patients who initiate vericiguat: Dialysis
Time frame: Baseline
characteristics of patients who initiate vericiguat: Time from recent WHF event
Time frame: Baseline
characteristics of patients who initiate vericiguat: Comorbidities
Time frame: Baseline
characteristics of patients who initiate vericiguat: setting
Time frame: Baseline
characteristics of patients who initiate vericiguat: cardiovascular procedure
Time frame: Baseline
characteristics of patients who initiate vericiguat: HF foundational therapy, prior index date
Time frame: Baseline
characteristics of patients who initiate vericiguat: Number of HF foundational therapy
Time frame: Baseline
adherence of vericiguat therapy for 1 year after treatment initiation: medication possession ratio (MPR)
Time frame: 1 year (after vericiguat initiation)
adherence of vericiguat therapy for 1 year after treatment initiation: proportion of days covered (PDC)
Time frame: 1 year (after vericiguat initiation)
persistence of vericiguat therapy for 1 year after treatment initiation: Duration of continuous treatment over the first year after the index date
Time frame: 1 year (after vericiguat initiation)
persistence of vericiguat therapy for 1 year after treatment initiation: percentage of patients with continuous treatment at Day 365
Time frame: 1 year (after vericiguat initiation)
Pattern description of dose titration of vericiguat over 1 year after treatment initiation: Day-to-day patterns of vericiguat
Time frame: 1 year (after vericiguat initiation)
Pattern description of dose titration of vericiguat over 1 year after treatment initiation: Time to up-titration of vericiguat from index date to Day 365
Time frame: 1 year (after vericiguat initiation)
Pattern description of dose titration of vericiguat over 1 year after treatment initiation: Time to up-titration to maximal daily dose of vericiguat from index date to Day 365
Time frame: 1 year (after vericiguat initiation)
Pattern description of Heart Failure (HF) therapy before and after vericiguat initiation
Time frame: Baseline and 1 year (after vericiguat initiation)
Pattern description of dose titration of HF therapy before and after vericiguat initiation
Time frame: Baseline and 1 year after vericiguat initiation
assess the change in laboratory and clinical parameters before and after vericiguat initiation
Time frame: Baseline and 180 days after vericiguat initiation
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 8 Oct 2025.
- 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.
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 and Chronic Heart Failure With Reduced Ejection Fraction, 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 3 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: finished, as of the sponsor's last update on 8 Oct 2025. 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?
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?
Incidence rates of clinical outcomes in patients who initiate vericiguat (time frame: Retrospective analysis from September 2016 to July 2024; Up to one year after vericiguat initiation). 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 8 Oct 2025.