Clinical trial NCT06516562: Demographic, Clinical, Biological, Treatment Characteristics and Cardiovascular Events of Patients With Heart Failure in Vietnam: a Multicenter Prospective Observational Study
Official title: Demographic, Clinical, Biological, Treatment Characteristics and Cardiovascular Events of Patients With Heart Failure in Vietnam: a Multicenter Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Heart Failure With Reduced Ejection Fraction
Heart Failure With Mid Range Ejection Fraction
Keywords: Patient registry
Heart failure
Prospective Observational Study
Demographic
Treatment characteristics
Prognosis
MACE
Lead sponsor: University Medical Center Ho Chi Minh City (UMC)
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All eligible patients discharged with a diagnosis of heart failure with reduced or mildly reduced ejection fraction.

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/)

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

Primary outcomes:
measure: All-cause mortality
timeFrame: 12 months
measure: Heart failure rehospitalization
timeFrame: 12 months
Secondary outcomes:
measure: Major adverse cardiovascular events
timeFrame: 12 months
measure: Guideline-directed medical therapy detail
timeFrame: 12 months
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: University Medical Center Ho Chi Minh City
Study officials:
affiliation: University Medical Center Ho Chi Minh City
name: Cong Thanh Nguyen, MD, MSc
role: STUDY_CHAIR
affiliation: University Medical Center Ho Chi Minh City
name: Thanh Hai Nam Phan, MD, MSc
role: STUDY_CHAIR
affiliation: University of Medicine and Pharmacy at Ho Chi Minh City
name: Quang Binh Truong, Professor
role: STUDY_DIRECTOR
affiliation: University of Medicine and Pharmacy at Ho Chi Minh City
name: Hoang Vu Vu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Ho Chi Minh City
name: Dang Duy Quang Pham, MD, MSc
role: STUDY_CHAIR
References:
citation: 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 Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available.
citation: 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/ehac151.