Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06363110
Status:
COMPLETED
Last Update Posted:
2024-07-03
First Post:
2024-04-09
Brief Title:
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
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
Titration Patterns Patient Characteristics and Hypotension Events Among Patients Initiating Vericiguat in Real World Settings in the United States US
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HOVER
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None