check_circleStudy Completed
Chronic heart failure with reduced ejection fraction
Bayer Identifier:
22724
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial purpose
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.
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.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
1400Trial Dates
April 2024 - June 2024Phase
N/ACould I Receive a placebo
NoProducts
Verquvo (Vericiguat, BAY1021189)Accepts Healthy Volunteer
NoWhere to participate
| Status | Institution | Location |
|---|---|---|
Completed | Bayer | Whippany, 07981, US |
Primary Outcome
- Number of patients having vericiguat daily dose of 2.5 mg, 5 mg and 10 mg at index datedate_rangeTime Frame:Retrospective data analysis from 01Jan2021 to 01Apr2023
- Number of patients having daily dose of 10 mg/day within the 90 days after vericiguat initiationdate_rangeTime Frame:Retrospective data analysis from 01Jan2021 to 01Jul2023
- Days from index date to first occurrence of 10 mg/day dosedate_rangeTime 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 perioddate_rangeTime Frame:Retrospective data analysis from 01Jan2021 to 01Jul2023
- Number of patients having any Vericiguat up-titration within the 90 days after vericiguat initiationVericiguat 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-update_rangeTime Frame:Retrospective data analysis from 01Jan2021 to 01Jul2023
- Number of patients having specific titration scenarios within the 90 days after vericiguat initiation7 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-update_rangeTime Frame:Retrospective data analysis from 01Jan2021 to 01Jul2023
Secondary Outcome
- Number of patients having hypotension or syncope in the entire 90 days after vericiguat initiation and by 30 days intervalsdate_rangeTime Frame:Retrospective data analysis from 01Jan2021 to 01Jul2023
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A