Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 10:05 PM
Study NCT ID:
NCT05658458
Status:
COMPLETED
Last Update Posted:
2024-10-08
First Post:
2022-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Learn How Well the Drug Vericiguat Works and How Safe it is Under Real World Conditions in Indian Participants After Worsening of a Long-term Heart Condition in Which the Left Side of the Heart Does Not Pump Blood as Well as it Should (Chronic Heart Failure With Reduced Ejection Fraction)
Sponsor:
Bayer
Organization:
Study Overview
Official Title:
A Phase IV Interventional Post Approval Trial to Investigate Effectiveness and Safety of Vericiguat Therapy in Indian Patients With Chronic Heart Failure With Reduced Ejection Fraction After a Worsening Heart Failure Event.
Status:
COMPLETED
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:
None
Brief Summary:
Researchers are looking for a better way to treat people who have chronic heart failure with reduced ejection fraction (HFrEF).
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. Despite various available treatments for long-term HFrEF, people may experience worsening of their condition, called worsening heart failure events. Worsening heart failure events require the patient to either stay in the hospital or receive special treatment to remove excess water from the body.
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 was recently approved in India for doctors to prescribe to people with HFrEF after they had a worsening heart failure event, with a request to specifically gather information on vericiguat therapy in Indians.
Therefore, the main purpose of this study is to learn more about how well vericiguat works in Indian people with HFrEF who receive vericiguat after a worsening heart failure event. Work well means to prevent:
* death due to heart and circulatory events, or
* hospital stays. Researchers will collect the number of participants treated with vericiguat who have either of this.
To find out how safe vericiguat is, researchers will also collect the number of participants who have medical problems during the study. Doctors keep track of all medical problems, even if they do not think the adverse events might be related to the study treatments.
The participants will take vericiguat as tablet by mouth and as prescribed by their doctors according to the local label.
Each participant will be in the study for approximately 1 year including a screening period of up to 1 month. Up to 8 visits to the study site are planned.
During the study, the study team will:
* check vital signs
* do physical examinations
* examine heart health using electrocardiogram ECG and if needed echocardiography
* take blood and urine samples
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. Despite various available treatments for long-term HFrEF, people may experience worsening of their condition, called worsening heart failure events. Worsening heart failure events require the patient to either stay in the hospital or receive special treatment to remove excess water from the body.
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 was recently approved in India for doctors to prescribe to people with HFrEF after they had a worsening heart failure event, with a request to specifically gather information on vericiguat therapy in Indians.
Therefore, the main purpose of this study is to learn more about how well vericiguat works in Indian people with HFrEF who receive vericiguat after a worsening heart failure event. Work well means to prevent:
* death due to heart and circulatory events, or
* hospital stays. Researchers will collect the number of participants treated with vericiguat who have either of this.
To find out how safe vericiguat is, researchers will also collect the number of participants who have medical problems during the study. Doctors keep track of all medical problems, even if they do not think the adverse events might be related to the study treatments.
The participants will take vericiguat as tablet by mouth and as prescribed by their doctors according to the local label.
Each participant will be in the study for approximately 1 year including a screening period of up to 1 month. Up to 8 visits to the study site are planned.
During the study, the study team will:
* check vital signs
* do physical examinations
* examine heart health using electrocardiogram ECG and if needed echocardiography
* take blood and urine samples
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?: