Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06516562
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
Demographic Clinical Biological Treatment Characteristics and Cardiovascular Events of Patients With Heart Failure in Vietnam a Multicenter Prospective Observational Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Demographic Clinical Biological Treatment Characteristics and Cardiovascular Events of Patients With Heart Failure in Vietnam a Multicenter Prospective Observational Study
Status:
RECRUITING
Status Verified Date:
2023-08
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:
MCR-HF
Brief Summary:
Describe the clinical characteristics paraclinical features and treatment during hospitalization as well as at 1 3 and 12 months post-discharge of heart failure patients at selected cardiovascular centers in Vietnam
Detailed Description:
Study Design Prospective cohort study
Study Subjects Patients discharged with a diagnosis of heart failure with reduced or mildly reduced ejection fraction
Inclusion Criteria
Patients aged 18 years and older
Diagnosed with heart failure at the time of discharge
Have an ejection fraction based on imaging modalities such as echocardiography or cardiac MRI recorded closest to the time of discharge showing a left ventricular ejection fraction of less than 50
Exclusion Criteria
Patients and their relatives do not have means of communication with healthcare staff phone computer messaging etc
Patients do not reside in Vietnam after discharge
Data Collection
All patients meeting the criteria at the time of discharge during the study period will be continuously included Information regarding demographic data clinical presentation biological markers and in-hospital treatment characteristics will be collected using standardized data definitions from EuroHeart data standards for heart failure
Periodically after hospital discharge eg 1 month 3 months 12 months post-discharge patients will be contacted by investigators to gather information on their current status medications and any cardiovascular events including rehospitalizations death and current medical treatment
Data entry will be performed using the REDCap project at the University of Medicine and Pharmacy Ho Chi Minh City httpsredcapumceduvn
Study Subjects Patients discharged with a diagnosis of heart failure with reduced or mildly reduced ejection fraction
Inclusion Criteria
Patients aged 18 years and older
Diagnosed with heart failure at the time of discharge
Have an ejection fraction based on imaging modalities such as echocardiography or cardiac MRI recorded closest to the time of discharge showing a left ventricular ejection fraction of less than 50
Exclusion Criteria
Patients and their relatives do not have means of communication with healthcare staff phone computer messaging etc
Patients do not reside in Vietnam after discharge
Data Collection
All patients meeting the criteria at the time of discharge during the study period will be continuously included Information regarding demographic data clinical presentation biological markers and in-hospital treatment characteristics will be collected using standardized data definitions from EuroHeart data standards for heart failure
Periodically after hospital discharge eg 1 month 3 months 12 months post-discharge patients will be contacted by investigators to gather information on their current status medications and any cardiovascular events including rehospitalizations death and current medical treatment
Data entry will be performed using the REDCap project at the University of Medicine and Pharmacy Ho Chi Minh City httpsredcapumceduvn
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