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Clinical Trials/NCT06516562
NCT06516562
Recruiting
Not Applicable

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

University Medical Center Ho Chi Minh City (UMC)1 site in 1 country2,500 target enrollmentAugust 1, 2023

Overview

Phase
Not Applicable
Intervention
Optimal treatment
Conditions
Heart Failure
Sponsor
University Medical Center Ho Chi Minh City (UMC)
Enrollment
2500
Locations
1
Primary Endpoint
Heart failure rehospitalization
Status
Recruiting
Last Updated
last year

Overview

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/)

Registry
clinicaltrials.gov
Start Date
August 1, 2023
End Date
June 1, 2028
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
University Medical Center Ho Chi Minh City (UMC)
Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Heart failure with reduced or mildly reduced ejection fraction

Intervention: Optimal treatment

Outcomes

Primary Outcomes

Heart failure rehospitalization

Time Frame: 12 months

Patient rehospitalization due to cardiovascular causes, excluding apparent non-cardiac causes.

All-cause mortality

Time Frame: 12 months

Death from any cause

Secondary Outcomes

  • Guideline-directed medical therapy detail(12 months)
  • Major adverse cardiovascular events(12 months)

Study Sites (1)

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