Chronic Heart Failure With Reduced Ejection FractionHOVERNCT06363110
An Observational Study to Learn More About Vericiguat Treatment Patterns and Its Safety in People With Chronic Heart Failure With Reduced Ejection Fraction in Routine Medical Care in the United States
An observational study of Chronic Heart Failure With Reduced Ejection Fraction, run by Bayer at 1 site in United States.
Trial summary
This is an observational study in which data already collected from people with chronic heart failure with reduced ejection fraction (HFrEF) 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
- 1,400 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2024to 24 Jun 2024
- 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: Adult patients who initiated vericiguat from closed claims during 01Jan2021 and 01Apr2023 and who have at least 6 months of prior observability.
Who may be able to join
- Patients with a first vericiguat fill from a closed pharmacy claim, defined as the index date, during the patient identification period spanning from 01 JAN 2021 - 01 APR 2023.
- Patients aged 18 years or older at index date.
- Patients with at least 180 days of medical and pharmacy enrollment (no gap) prior to index date (inclusive).
Who cannot join
- Patients with any open pharmacy claim in the 180-day prior to index date
- Patients with an open pharmacy claim for vericiguat at index date and in the 90 days after index date
- Patients with missing age (last value observed) and gender (last value observed) at index date.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Titration Patterns, Patient Characteristics and Hypotension Events Among Patients Initiating Vericiguat in Real World Settings in the United States (US)
This is an observational study in which data already collected from people with chronic heart failure with reduced ejection fraction (HFrEF) are studied.
In observational studies, only observations are made, without participants receiving any advice or any changes to healthcare.
Read more
Chronic HFrEF is a long-term condition in which the heart becomes 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 study treatment, 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. As a result, the heart can pump better.
It is already approved for doctors to prescribe to people with chronic HFrEF in the United States (US) who are stabilized after a recent "decompensation event". The treatment with vericiguat starts at a low dose, which should be increased gradually to the target dose based on how a patient tolerates the treatment.
The participants in this study are already receiving treatment with vericiguat as part of their regular care from their doctors.
The main purpose of the study is to learn more about the dosage pattern of vericiguat in people with chronic HFrEF in the US. To do this, researchers will collect the following information for 3 months after participants' first dose of vericiguat:
- starting dose of vericiguat
- daily changes in dosage pattern
- time taken to reach the target dose
- number and percentage of participants:
- with specific changes in dosage pattern
- reaching the target dose of vericiguat
They will also collect information on how often low blood pressure or fainting occurs, which are well known events in people with chronic HFrEF.
The data will come from the participants' information stored in a database called the HealthVerity HF dataset. Data collected will be from people with chronic HFrEF who started taking vericiguat between January 2021 and April 2023.
Researchers will only look at the health records of participants in the US.
Researchers will track participants' data and will collect information for a maximum of 6 months before and 3 months after their first dose of vericiguat.
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 (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
Follow clinical practice/administration
| Study group | Role | What they receive |
|---|---|---|
| Adult patients initiating vericiguat | Adult patients initiating vericiguat in the US. Retrospective single-arm cohort analysis using HealthVerity Heart Failure (HF) dataset licensed by Bayer. Receives: Drug: Vericiguat (Verquvo, BAY1021189) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients having vericiguat daily dose of 2.5 mg, 5 mg and 10 mg at index date
Measured: Retrospective data analysis from 01Jan2021 to 01Apr2023
Number of patients having daily dose of 10 mg/day within the 90 days after vericiguat initiation
Measured: Retrospective data analysis from 01Jan2021 to 01Jul2023
Days from index date to first occurrence of 10 mg/day dose
Measured: Retrospective data analysis from 01Jan2021 to 01Jul2023
Number of patients who received a dose of 2.5 mg/day, 5 mg/day and 10 mg/day, or discontinued drug therapy each day over the 90-day follow-up period
Measured: Retrospective data analysis from 01Jan2021 to 01Jul2023
Number of patients having any Vericiguat up-titration within the 90 days after vericiguat initiation
Vericiguat up-titration is defined as first vericiguat prescription with a higher dose compared to the previous vericiguat prescription:
- 2.5 mg/day at index date followed by any dose >2.5 mg/day during follow-up, OR
- 5 mg/day at index date followed by any dose >5 mg/day during follow-up
Measured: Retrospective data analysis from 01Jan2021 to 01Jul2023
Number of patients having specific titration scenarios within the 90 days after vericiguat initiation
7 titration patterns:
- Vericiguat dose of 2.5 mg/day at index date, without 5 mg/day dose and without 10 mg/day dose observed during follow-up
- Vericiguat dose of 2.5 mg/day at index date followed by 5.0 mg/day dose during follow-up and without 10 mg/day dose observed during follow-up
- Vericiguat dose of 2.5 mg/day at index date, followed by 5 mg/day dose, and followed by 10 mg/day dose during follow-up
- Vericiguat dose of 5.0 mg/day at index date without 10 mg/day dose observed during follow-up
- Vericiguat dose of 5 mg/day at index date followed by 10 mg/day dose during follow-up
- Vericiguat dose of 2.5 mg/day at index date, followed by 10 mg/day dose and without 5 mg/day dose observed during follow-up
- Vericiguat dose of 10 mg/day at index date without 2.5 mg/day dose and without 5 mg/day dose observed during follow-up
Measured: Retrospective data analysis from 01Jan2021 to 01Jul2023
Secondary outcomes (1)
Number of patients having hypotension or syncope in the entire 90 days after vericiguat initiation and by 30 days intervals
Measured: Retrospective data analysis from 01Jan2021 to 01Jul2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start10 Apr 2024
- Primary completion24 Jun 2024
- Study completion24 Jun 2024
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
- 1,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363110
- Sponsor's protocol ID
- 22724
- Acronym
- HOVER
- Status last verified
- Jun 2024
- First submitted
- 9 Apr 2024
- Last updated
- 3 Jul 2024
- 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 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Titration Patterns, Patient Characteristics and Hypotension Events Among Patients Initiating Vericiguat in Real World Settings in the United States (US)
- ClinicalTrials.gov ID
- NCT06363110
- Acronym / sponsor ID
- HOVER / 22724
- Keywords
- HFrEF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,400 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 24 Jun 2024 (actual)
- Study completion
- 24 Jun 2024 (actual)
- First posted
- 12 Apr 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 with reduced ejection fraction (HFrEF) are studied.
In observational studies, only observations are made, without participants receiving any advice or any changes to healthcare.
Chronic HFrEF is a long-term condition in which the heart becomes 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 study treatment, 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. As a result, the heart can pump better.
It is already approved for doctors to prescribe to people with chronic HFrEF in the United States (US) who are stabilized after a recent "decompensation event". The treatment with vericiguat starts at a low dose, which should be increased gradually to the target dose based on how a patient tolerates the treatment.
The participants in this study are already receiving treatment with vericiguat as part of their regular care from their doctors.
The main purpose of the study is to learn more about the dosage pattern of vericiguat in people with chronic HFrEF in the US. To do this, researchers will collect the following information for 3 months after participants' first dose of vericiguat:
- starting dose of vericiguat
- daily changes in dosage pattern
- time taken to reach the target dose
- number and percentage of participants:
- with specific changes in dosage pattern
- reaching the target dose of vericiguat
They will also collect information on how often low blood pressure or fainting occurs, which are well known events in people with chronic HFrEF.
The data will come from the participants' information stored in a database called the HealthVerity HF dataset. Data collected will be from people with chronic HFrEF who started taking vericiguat between January 2021 and April 2023.
Researchers will only look at the health records of participants in the US.
Researchers will track participants' data and will collect information for a maximum of 6 months before and 3 months after their first dose of vericiguat.
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
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients initiating vericiguat | – | Drug: Vericiguat (Verquvo, BAY1021189)Adult patients initiating vericiguat in the US. Retrospective single-arm cohort analysis using HealthVerity Heart Failure (HF) dataset licensed by Bayer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients who initiated vericiguat from closed claims during 01Jan2021 and 01Apr2023 and who have at least 6 months of prior observability.
Key inclusion criteria (3 listed)
- Patients with a first vericiguat fill from a closed pharmacy claim, defined as the index date, during the patient identification period spanning from 01 JAN 2021 - 01 APR 2023.
- Patients aged 18 years or older at index date.
- Patients with at least 180 days of medical and pharmacy enrollment (no gap) prior to index date (inclusive).
Key exclusion criteria (3 listed)
- Patients with any open pharmacy claim in the 180-day prior to index date
- Patients with an open pharmacy claim for vericiguat at index date and in the 90 days after index date
- Patients with missing age (last value observed) and gender (last value observed) at index date.
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)Follow clinical practice/administration | Drug | Adult patients initiating vericiguat |
Primary outcome
Number of patients having vericiguat daily dose of 2.5 mg, 5 mg and 10 mg at index date
Time frame: Retrospective data analysis from 01Jan2021 to 01Apr2023
Number of patients having daily dose of 10 mg/day within the 90 days after vericiguat initiation
Time frame: Retrospective data analysis from 01Jan2021 to 01Jul2023
Days from index date to first occurrence of 10 mg/day dose
Time frame: Retrospective data analysis from 01Jan2021 to 01Jul2023
Number of patients who received a dose of 2.5 mg/day, 5 mg/day and 10 mg/day, or discontinued drug therapy each day over the 90-day follow-up period
Time frame: Retrospective data analysis from 01Jan2021 to 01Jul2023
Number of patients having any Vericiguat up-titration within the 90 days after vericiguat initiation
Time frame: Retrospective data analysis from 01Jan2021 to 01Jul2023
Vericiguat up-titration is defined as first vericiguat prescription with a higher dose compared to the previous vericiguat prescription: * 2.5 mg/day at index date followed by any dose >2.5 mg/day during follow-up, OR * 5 mg/day at index date followed by any dose >5 mg/day during follow-up
Number of patients having specific titration scenarios within the 90 days after vericiguat initiation
Time frame: Retrospective data analysis from 01Jan2021 to 01Jul2023
7 titration patterns: * Vericiguat dose of 2.5 mg/day at index date, without 5 mg/day dose and without 10 mg/day dose observed during follow-up * Vericiguat dose of 2.5 mg/day at index date followed by 5.0 mg/day dose during follow-up and without 10 mg/day dose observed during follow-up * Vericiguat dose of 2.5 mg/day at index date, followed by 5 mg/day dose, and followed by 10 mg/day dose during follow-up * Vericiguat dose of 5.0 mg/day at index date without 10 mg/day dose observed during follow-up * Vericiguat dose of 5 mg/day at index date followed by 10 mg/day dose during follow-up * Vericiguat dose of 2.5 mg/day at index date, followed by 10 mg/day dose and without 5 mg/day dose observed during follow-up * Vericiguat dose of 10 mg/day at index date without 2.5 mg/day dose and without 5 mg/day dose observed during follow-up
1 secondary outcome
Number of patients having hypotension or syncope in the entire 90 days after vericiguat initiation and by 30 days intervals
Time frame: Retrospective data analysis from 01Jan2021 to 01Jul2023
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 3 Jul 2024.
- 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 United States.
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 3 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 3 Jul 2024. 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 United States. 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?
Number of patients having vericiguat daily dose of 2.5 mg, 5 mg and 10 mg at index date (time frame: Retrospective data analysis from 01Jan2021 to 01Apr2023). The study lists 6 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 3 Jul 2024.