Chronic Heart Failure With Reduced Ejection FractionROVERNCT06486844
An Observational Study Called ROVER to Learn More About How Well Vericiguat Works in People Who Were Newly Treated With Vericiguat in Routine Medical Care in Germany
An observational study of Chronic Heart Failure With Reduced Ejection Fraction, run by Bayer at 1 site in Germany.
Trial summary
This is an observational study in which data already collected from people treated with vericiguat are studied. In observational studies, only observations are made without participants receiving any advice or any changes to healthcare. 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
- 500 participants
- Where
- 1 siteGermany
- Study dates
- 5 Jul 2024to 31 Aug 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: All patients with their first vericiguat prescription since market authorization in September 2021 who are aged 18 years or older will be included in the study.
Who may be able to join
- Patients with an initial prescription of Vericiguat (index date) according to ATC Code C01DX22.
- At least 18 years or older on the initial prescription of Vericiguat.
Who cannot join
- No exclusion criteria for any population will be applied.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real World Outcomes of Patients Treated With Vericiguat in German Routine Care
This is an observational study in which data already collected from people treated with vericiguat are studied.
In observational studies, only observations are made without participants receiving any advice or any changes to healthcare.
Read more
Chronic heart failure with reduced ejection fraction (HFrEF) is a long-term condition that occurs when the heart is weak and cannot pump enough blood to the rest of the body with each heartbeat. This leads to a reduced supply of oxygen which the body requires to function properly. The common symptoms include breathlessness, weakness, fatigue, and swelling in the ankles and legs. If left untreated, heart failure can lead to other serious health problems, including damage to other organs, which may result in hospital stays and even death.
Vericiguat works by increasing the activity of an enzyme called soluble guanylate cyclase (sGC), which relaxes the blood vessels and allows more blood to flow through. As a result, the heart is able to pump better.
Vericiguat is available in Germany for the treatment of HFrEF based on the results of a study called VICTORIA. The VICTORIA study showed that vericiguat helps in lowering the chances of death or hospitalization due to heart failure. However, there is limited information available about the use of vericiguat for the treatment of HFrEF under real-world conditions in routine medical care.
The main purpose of this study is to collect information about how well vericiguat works in people with HFrEF who were newly treated with vericiguat. In addition, researchers will collect information about participants' basic characteristics, including their age, gender, other health conditions they might have, and the medicines they might be taking.
The data will come from 2 German health databases including people who newly started vericiguat treatment between September 2021 and September 2023.
- Being tested
- Vericiguat (Verquvo, BAY1021189)
- Keywords
- HFrEF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vericiguat (Verquvo, BAY1021189)Drug
Vericiguat was given following routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Patients who received vericiguat prescription | Patients who were new users of vericiguat between September 2021 and September 2023 from the InGef database and the WIG2 database. Receives: Drug: Vericiguat (Verquvo, BAY1021189) |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality rates after initiation of vericiguat
Number of patients who died between the "Vericiguat index date" and "cohort exit" according to their death date.
Measured: Between September 2021 and September 2023
All-cause related hospitalization rates after initiation of vericiguat
Sum of all fully hospitalized cases of all patients between the "Vericiguat index date" and "cohort exit".
Measured: Between September 2021 and September 2023
Heart failure related hospitalization rates after initiation of vericiguat
Sum of all fully hospitalized cases with a main or secondary inpatient diagnosis according to ICD-10 GM Code I50.x or I11.0 between the "Vericiguat index date" and "cohort exit".
Measured: Between September 2021 and September 2023
Secondary outcomes (6)
Adherence of vericiguat drug use
Adherence will be assessed using the Medical Possession Ratio (MPR=days of supply/treatment duration).
Measured: Between September 2021 and September 2023
Titration pattern of vericiguat drug use
Titration patterns will be assessed by investigating indicators such as the starting dose, the maximum dose reached as well as the time until up-titration.
Measured: Between September 2021 and September 2023
Patient persistence of vericiguat drug use
Persistence will be calculated via the time until discontinuation of vericiguat.
Measured: Between September 2021 and September 2023
Socio-demographic characteristics of patients initiating vericiguat at baseline
Sex and age groups.
Measured: Between September 2021 and September 2023
Clinical characteristics of patients initiating vericiguat at baseline
Pre-defined comorbidities, pre-defined comedications, all-cause hospitalization, worsening hart failure event, etc.
Measured: Between September 2021 and September 2023
Medication of interest in the 3 months before and after initiation of vericiguat
Measured: Between September 2021 and September 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start5 Jul 2024
- Primary completion31 Aug 2025
- Study completion31 Aug 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
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486844
- Sponsor's protocol ID
- 22829
- Acronym
- ROVER
- Status last verified
- Aug 2026
- First submitted
- 27 Jun 2024
- Last updated
- 31 Aug 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 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Outcomes of Patients Treated With Vericiguat in German Routine Care
- ClinicalTrials.gov ID
- NCT06486844
- Acronym / sponsor ID
- ROVER / 22829
- Keywords
- HFrEF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 5 Jul 2024 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 5 Jul 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 treated with vericiguat are studied.
In observational studies, only observations are made without participants receiving any advice or any changes to healthcare.
Chronic heart failure with reduced ejection fraction (HFrEF) is a long-term condition that occurs when the heart is weak and cannot pump enough blood to the rest of the body with each heartbeat. This leads to a reduced supply of oxygen which the body requires to function properly. The common symptoms include breathlessness, weakness, fatigue, and swelling in the ankles and legs. If left untreated, heart failure can lead to other serious health problems, including damage to other organs, which may result in hospital stays and even death.
Vericiguat works by increasing the activity of an enzyme called soluble guanylate cyclase (sGC), which relaxes the blood vessels and allows more blood to flow through. As a result, the heart is able to pump better.
Vericiguat is available in Germany for the treatment of HFrEF based on the results of a study called VICTORIA. The VICTORIA study showed that vericiguat helps in lowering the chances of death or hospitalization due to heart failure. However, there is limited information available about the use of vericiguat for the treatment of HFrEF under real-world conditions in routine medical care.
The main purpose of this study is to collect information about how well vericiguat works in people with HFrEF who were newly treated with vericiguat. In addition, researchers will collect information about participants' basic characteristics, including their age, gender, other health conditions they might have, and the medicines they might be taking.
The data will come from 2 German health databases including people who newly started vericiguat treatment between September 2021 and September 2023.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who received vericiguat prescription | – | Drug: Vericiguat (Verquvo, BAY1021189)Patients who were new users of vericiguat between September 2021 and September 2023 from the InGef database and the WIG2 database. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with their first vericiguat prescription since market authorization in September 2021 who are aged 18 years or older will be included in the study.
Key inclusion criteria (2 listed)
- Patients with an initial prescription of Vericiguat (index date) according to ATC Code C01DX22.
- At least 18 years or older on the initial prescription of Vericiguat.
Key exclusion criteria (1 listed)
- No exclusion criteria for any population will be applied.
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)Vericiguat was given following routine clinical practice. | Drug | Patients who received vericiguat prescription |
Primary outcome
All-cause mortality rates after initiation of vericiguat
Time frame: Between September 2021 and September 2023
Number of patients who died between the "Vericiguat index date" and "cohort exit" according to their death date.
All-cause related hospitalization rates after initiation of vericiguat
Time frame: Between September 2021 and September 2023
Sum of all fully hospitalized cases of all patients between the "Vericiguat index date" and "cohort exit".
Heart failure related hospitalization rates after initiation of vericiguat
Time frame: Between September 2021 and September 2023
Sum of all fully hospitalized cases with a main or secondary inpatient diagnosis according to ICD-10 GM Code I50.x or I11.0 between the "Vericiguat index date" and "cohort exit".
6 secondary outcomes
Adherence of vericiguat drug use
Time frame: Between September 2021 and September 2023
Titration pattern of vericiguat drug use
Time frame: Between September 2021 and September 2023
Patient persistence of vericiguat drug use
Time frame: Between September 2021 and September 2023
Socio-demographic characteristics of patients initiating vericiguat at baseline
Time frame: Between September 2021 and September 2023
Clinical characteristics of patients initiating vericiguat at baseline
Time frame: Between September 2021 and September 2023
Medication of interest in the 3 months before and after initiation of vericiguat
Time frame: Between September 2021 and September 2023
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 31 Aug 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 Germany.
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 2 inclusion and 1 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 31 Aug 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 Germany. 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?
All-cause mortality rates after initiation of vericiguat (time frame: Between September 2021 and September 2023). The study lists 3 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 31 Aug 2026.