Demographic, Clinical, Biological, Treatment Characteristics and Cardiovascular Events of Patients With Heart Failure in Vietnam: a Multicenter Prospective Observational Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Optimal treatment.
- Who it may be relevant to
- Registry conditions: Heart Failure, Heart Failure With Reduced Ejection Fraction, Heart Failure With Mid Range Ejection Fraction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Vietnam
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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/)
Interventions
- Drug Optimal treatment
Optimal treatment using current National Guidelines for the diagnosis and treatment of chronic heart failure
Primary outcome measures
- All-cause mortality [Time frame: 12 months]
- Heart failure rehospitalization [Time frame: 12 months]
Secondary outcome measures (2)
- Major adverse cardiovascular events [Time frame: 12 months]
- Guideline-directed medical therapy detail [Time frame: 12 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Case-control
Study locations
Vietnam · 1 center
- University Medical Center Ho Chi Minh City — Ho Chi Minh City
Publications
- McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Gro PMID 34447992
- Aktaa S, Batra G, Cleland JGF, Coats A, Lund LH, McDonagh T, Rosano G, Seferovic P, Vasko P, Wallentin L, Maggioni AP, Casadei B, Gale CP; Heart Failure Association of the European Society of Cardiology. Data standards for heart failure: the European Unified Registries for Heart Care Evaluation and Randomized Trials (EuroHeart). Eur Heart J. 2022 Jun 14;43(23):2185-2195. doi: 10.1093/eurheartj/eha PMID 35443059
Identifiers
NCT: NCT06516562 · 43/2024/HĐ-ĐHYD