Ignite Creation Date:
2024-07-17 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06486844
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-27
Brief Title:
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
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
Real World Outcomes of Patients Treated With Vericiguat in German Routine Care
Status:
RECRUITING
Status Verified Date:
2024-10
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:
ROVER
Brief 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
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
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
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