Demographic, Clinical, Biological, Treatment Characteristics and Cardiovascular Events of Patients With Heart Failure in Vietnam: a Multicenter Prospective Observational Study

Recruiting

• Conditions: Heart Failure With Mid Range Ejection Fraction; Heart Failure; Heart Failure With Reduced Ejection Fraction
• Interventions: Drug: Optimal treatment

• Registration Number: NCT06516562
• Lead Sponsor: University Medical Center Ho Chi Minh City (UMC)

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 (e.g., 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 (https://redcap.umc.edu.vn/)

Study Timeline

• Study Start: 2023-08-01
• Study First Submitted: 2024-07-17
• Study First Submitted QC: 2024-07-17
• Study First Posted: 2024-07-24
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06
• Primary Completion: 2027-08-01
• Study Completion: 2028-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2500

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%

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Heart failure with reduced or mildly reduced ejection fraction	Optimal treatment	-

Primary Outcome Measures

Name	Time	Method
Heart failure rehospitalization	12 months	Patient rehospitalization due to cardiovascular causes, excluding apparent non-cardiac causes.
All-cause mortality	12 months	Death from any cause

Secondary Outcome Measures

Name	Time	Method
Guideline-directed medical therapy detail	12 months	Information regarding guideline-directed medical therapy, including medications used and dose titration over time.
Major adverse cardiovascular events	12 months	Acute myocardial infarction, stroke or death from any cause

Trial Locations

Locations (1)

University Medical Center Ho Chi Minh City; 🇻🇳 Ho Chi Minh City, Vietnam