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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vericiguat (Verquvo, BAY1021189) | Drug | Follow clinical practice/administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients having vericiguat daily dose of 2.5 mg, 5 mg and 10 mg at index date | Retrospective data analysis from 01Jan2021 to 01Apr2023 | |
| Number of patients having daily dose of 10 mg/day within the 90 days after vericiguat initiation | Retrospective data analysis from 01Jan2021 to 01Jul2023 | |
| Days from index date to first occurrence of 10 mg/day dose | 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 | 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:
| Retrospective data analysis from 01Jan2021 to 01Jul2023 |
| Number of patients having specific titration scenarios within the 90 days after vericiguat initiation | 7 titration patterns:
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients having hypotension or syncope in the entire 90 days after vericiguat initiation and by 30 days intervals | Retrospective data analysis from 01Jan2021 to 01Jul2023 |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients who initiated vericiguat from closed claims during 01Jan2021 and 01Apr2023 and who have at least 6 months of prior observability.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bayer | Whippany | New Jersey | 07981 | United States |
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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| Retrospective data analysis from 01Jan2021 to 01Jul2023 |
| ID | Term |
|---|---|
| C000603960 | vericiguat |
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