Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:57 AM
Study NCT ID:
NCT05728502
Status:
RECRUITING
Last Update Posted:
2025-10-06
First Post:
2023-02-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Observational Study, Called VERI-China, to Learn More About How Well Vericiguat Works and How Safe it is in Real-world Setting in People With Chronic Heart Failure With Reduced Ejection Fraction (HFrEF) in China
Sponsor:
Bayer
Organization:
Study Overview
Official Title:
A Multi-center, Two-arm, Open-label, Externally Controlled, Post-marketing Study of the Effectiveness and Safety of Vericiguat in HFrEF Patients in China
Status:
RECRUITING
Status Verified Date:
2025-10
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:
VERI-China
Brief Summary:
This is an observational study in which data from people in China with chronic heart failure with reduced ejection fraction (HFrEF) who will be receiving vericiguat treatment are collected. Vericiguat treatment will be compared to available data on standard of care (SOC) treatment. In observational studies, only observations are made without specified advice or interventions.
HFrEF is a long-term condition where the left side of the heart does not pump blood out to the body as well as it should. Blood and fluid may collect in the lungs, blood vessels, and tissues causing shortness of breath or tiredness. Over time, heart failure can lead to other serious medical conditions that may result in hospital stays and death.
The drug vericiguat works by increasing the activity of an enzyme called soluble guanylate cyclase (sGC). The sGC enzyme helps to regulate the heart and blood circulation. Vericiguat is already available in China and other countries for doctors to prescribe to people with heart failure. Vericiguat has already been studied in previous clinical studies. However, the data from these studies were restricted by inclusion and exclusion criteria. Therefore, this real-world study will collect important data from real-world setting in China.
The main purpose of this study is to collect more data on how well vericiguat works compared with current SOC in Chinese people with HFrEF under everyday conditions.
Working well means that the treatment can prevent the following from happening:
* death due to heart and circulatory events,
* a hospital stay due to heart conditions (failure).
In addition, the study team will gather more information about how safe the study drug vericiguat is for Chinese people with HFrEF. To do this, the researchers will collect all medical problems the participants have during the study. These medical problems are also known as "adverse events" and may or may not be related to the study treatment.
Subsequently, the study team will compare the data between participants who received the study drug vericiguat and those who received SOC. The SOC is the currently appropriate treatment in accordance with scientific evidence and agreed upon in collaboration between medical experts for HFrEF.
The participants will take vericiguat as prescribed by their doctors during routine practice according to the approved product information. For the vericiguat group, data will be collected at routine visits, which are not mandated by this study. The data for the comparison (SOC group) will come from a database called China Heart Failure Center. These data will be collected retrospectively for a comparable period of time.
The following data from the study participants will be documented during visits that take place in routine practice every 3 months:
* underlying and concomitant diseases,
* prior medication,
* laboratory parameters,
* vital signs such as blood pressure, heart rate,
* results of cardiac exams (e.g. echocardiography),
* information about how and in which amount vericiguat is usually given to patients.
The participants will be treated with vericiguat and followed up to 12 months or until they leave the study, whatever comes first.
HFrEF is a long-term condition where the left side of the heart does not pump blood out to the body as well as it should. Blood and fluid may collect in the lungs, blood vessels, and tissues causing shortness of breath or tiredness. Over time, heart failure can lead to other serious medical conditions that may result in hospital stays and death.
The drug vericiguat works by increasing the activity of an enzyme called soluble guanylate cyclase (sGC). The sGC enzyme helps to regulate the heart and blood circulation. Vericiguat is already available in China and other countries for doctors to prescribe to people with heart failure. Vericiguat has already been studied in previous clinical studies. However, the data from these studies were restricted by inclusion and exclusion criteria. Therefore, this real-world study will collect important data from real-world setting in China.
The main purpose of this study is to collect more data on how well vericiguat works compared with current SOC in Chinese people with HFrEF under everyday conditions.
Working well means that the treatment can prevent the following from happening:
* death due to heart and circulatory events,
* a hospital stay due to heart conditions (failure).
In addition, the study team will gather more information about how safe the study drug vericiguat is for Chinese people with HFrEF. To do this, the researchers will collect all medical problems the participants have during the study. These medical problems are also known as "adverse events" and may or may not be related to the study treatment.
Subsequently, the study team will compare the data between participants who received the study drug vericiguat and those who received SOC. The SOC is the currently appropriate treatment in accordance with scientific evidence and agreed upon in collaboration between medical experts for HFrEF.
The participants will take vericiguat as prescribed by their doctors during routine practice according to the approved product information. For the vericiguat group, data will be collected at routine visits, which are not mandated by this study. The data for the comparison (SOC group) will come from a database called China Heart Failure Center. These data will be collected retrospectively for a comparable period of time.
The following data from the study participants will be documented during visits that take place in routine practice every 3 months:
* underlying and concomitant diseases,
* prior medication,
* laboratory parameters,
* vital signs such as blood pressure, heart rate,
* results of cardiac exams (e.g. echocardiography),
* information about how and in which amount vericiguat is usually given to patients.
The participants will be treated with vericiguat and followed up to 12 months or until they leave the study, whatever comes first.
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?: