Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT04915118
Status:
COMPLETED
Last Update Posted:
2022-12-02
First Post:
2021-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study Called NATION-OS to Learn About the Link Between N-terminal proBNP (NT-proBNP) Levels and Medical Problems Due to Heart Failure (HF) in German Patients With HF
Sponsor:
Bayer
Organization:
Study Overview
Official Title:
NT-proBNP Assessment in a HFrEF Population in Germany
Status:
COMPLETED
Status Verified Date:
2022-11
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:
NATION-OS
Brief Summary:
Researchers are looking for a better way to treat heart failure (HF), a condition in which the heart does not pump blood as well as it should.
Research has shown that the levels of a hormone called N-terminal proBNP (NT-proBNP) in the body can be used for differential diagnosing of HF. NT-proBNP is released by the heart when there is an increase in heart pressure. The levels of NT-proBNP can indicate whether medical problems are likely to happen due to HF. These medical problems are called "decompensation events." The higher a person's NT-proBNP levels is expected, the higher their risk of developing HF and having decompensation events.
So, the researchers in this study want to learn about NT-proBNP levels and decompensation events in German patients with a common type of HF called heart failure with reduced ejection fraction (HFrEF). In patients with HFrEF, the muscle on the left chamber of the heart does not pump blood as well as it should. The researchers will collect information from patients and their health records for about 300 adult patients in Germany with HFrEF who have been receiving standard of care treatment for their condition. Standard of care treatments are treatments that doctors commonly use to treat patients.
The researchers will study and record the levels of NT-proBNP levels and any changes in the health of the patients at time of NT-proBNP measurement.
The researchers will collect this information between May 2021 and September 2021.
The patients in this study :
* have had any HF-decompensation event since January 2016
* have had at least 1 NT-proBNP measurement done before the study
The researchers will collect the following information about the patients:
* the results of NT-proBNP measurements
* the date of the NT-proBNP measurements
* the number and type of decompensation events
Research has shown that the levels of a hormone called N-terminal proBNP (NT-proBNP) in the body can be used for differential diagnosing of HF. NT-proBNP is released by the heart when there is an increase in heart pressure. The levels of NT-proBNP can indicate whether medical problems are likely to happen due to HF. These medical problems are called "decompensation events." The higher a person's NT-proBNP levels is expected, the higher their risk of developing HF and having decompensation events.
So, the researchers in this study want to learn about NT-proBNP levels and decompensation events in German patients with a common type of HF called heart failure with reduced ejection fraction (HFrEF). In patients with HFrEF, the muscle on the left chamber of the heart does not pump blood as well as it should. The researchers will collect information from patients and their health records for about 300 adult patients in Germany with HFrEF who have been receiving standard of care treatment for their condition. Standard of care treatments are treatments that doctors commonly use to treat patients.
The researchers will study and record the levels of NT-proBNP levels and any changes in the health of the patients at time of NT-proBNP measurement.
The researchers will collect this information between May 2021 and September 2021.
The patients in this study :
* have had any HF-decompensation event since January 2016
* have had at least 1 NT-proBNP measurement done before the study
The researchers will collect the following information about the patients:
* the results of NT-proBNP measurements
* the date of the NT-proBNP measurements
* the number and type of decompensation events
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: