Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06632483
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
An Observational Study to Learn More About How Safe Vericiguat is and How Well It Works in Indian People with Chronic Heart Failure with Reduced Ejection Fraction and Worsening Chronic Heart Failure Under Real World Conditions
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Retrospective Non-interventional Database Study for the Evaluation of Real-world Drug Use Patterns Clinical Characteristics and Clinical Outcomes in Patients Initiated on Vericiguat in India
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an observational study in which data already collected from people with chronic HFrEF heart failure with reduced ejection fraction who have experienced worsening heart failure are studied
Chronic 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 even death
The study drug vericiguat is already approved for doctors to prescribe to people with worsening of heart failure with chronic HFrEF in India
Vericiguat increases the activity of an enzyme called soluble guanylate cyclase sGC which relaxes the blood vessels allowing more blood to flow through As a result the heart is able to pump better
The participants in this study are already receiving treatment with vericiguat as part of their regular care from their doctors There is currently limited real-world data on the use of vericiguat Furthermore discussing whether vericiguat treatment should start early in people with heart failure can help doctors manage these people better
The main purpose of this study is to collect information about how well vericiguat works and how safe it is in Indian people with chronic HFrEF who have experienced worsening heart failure To do this researchers will collect the following information
participants characteristics including age sex height weight and medical history
additional medicines participants have taken with vericiguat
other treatment options participants have taken for the treatment of heart failure
levels of NT-pro BNP in participants blood at least one month before taking vericiguat NT-proBNP is made by heart muscles People with heart diseases have increased levels of NT-proBNP in their blood Measuring NT-proBNP levels in the blood can help doctors identify heart disease
number of participants from India divided into four zones-North South East and West
categorization of participants based on how heart failure limits physical activity and classification of heart failure by cause
change in heart function measured by how much blood the left side of the heart can pump out
number of hospitalizations and number of participants who died due to heart-related and non-heart-related events
number of participants who experienced low blood pressure or fainting after starting treatment with vericiguat
participants who discontinued treatment with vericiguat due to low blood pressure or fainting
The data will come from the participants hospital medical and electronic healthcare records Data collected will be from Indian people with chronic HFrEF who started taking vericiguat between September 2022 and August 2023
Researchers will track participants data and will follow them until Feb 2024 In this study only available data from routine care are collected No visits or tests are required as part of this study
Chronic 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 even death
The study drug vericiguat is already approved for doctors to prescribe to people with worsening of heart failure with chronic HFrEF in India
Vericiguat increases the activity of an enzyme called soluble guanylate cyclase sGC which relaxes the blood vessels allowing more blood to flow through As a result the heart is able to pump better
The participants in this study are already receiving treatment with vericiguat as part of their regular care from their doctors There is currently limited real-world data on the use of vericiguat Furthermore discussing whether vericiguat treatment should start early in people with heart failure can help doctors manage these people better
The main purpose of this study is to collect information about how well vericiguat works and how safe it is in Indian people with chronic HFrEF who have experienced worsening heart failure To do this researchers will collect the following information
participants characteristics including age sex height weight and medical history
additional medicines participants have taken with vericiguat
other treatment options participants have taken for the treatment of heart failure
levels of NT-pro BNP in participants blood at least one month before taking vericiguat NT-proBNP is made by heart muscles People with heart diseases have increased levels of NT-proBNP in their blood Measuring NT-proBNP levels in the blood can help doctors identify heart disease
number of participants from India divided into four zones-North South East and West
categorization of participants based on how heart failure limits physical activity and classification of heart failure by cause
change in heart function measured by how much blood the left side of the heart can pump out
number of hospitalizations and number of participants who died due to heart-related and non-heart-related events
number of participants who experienced low blood pressure or fainting after starting treatment with vericiguat
participants who discontinued treatment with vericiguat due to low blood pressure or fainting
The data will come from the participants hospital medical and electronic healthcare records Data collected will be from Indian people with chronic HFrEF who started taking vericiguat between September 2022 and August 2023
Researchers will track participants data and will follow them until Feb 2024 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?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None