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

NCT ID: NCT06516562

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-01

Study Completion Date

2028-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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/)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure Heart Failure With Reduced Ejection Fraction Heart Failure With Mid Range Ejection Fraction

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Patient registry Heart failure Prospective Observational Study Demographic Treatment characteristics Prognosis MACE

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Heart failure with reduced or mildly reduced ejection fraction

Optimal treatment

Intervention Type DRUG

Optimal treatment using current National Guidelines for the diagnosis and treatment of chronic heart failure

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Optimal treatment

Optimal treatment using current National Guidelines for the diagnosis and treatment of chronic heart failure

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Medical Center Ho Chi Minh City (UMC)

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Cong Thanh Nguyen, MD, MSc

Role: STUDY_CHAIR

University Medical Center Ho Chi Minh City

Thanh Hai Nam Phan, MD, MSc

Role: STUDY_CHAIR

University Medical Center Ho Chi Minh City

Quang Binh Truong, Professor

Role: STUDY_DIRECTOR

University of Medicine and Pharmacy at Ho Chi Minh City

Hoang Vu Vu, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Medicine and Pharmacy at Ho Chi Minh City

Dang Duy Quang Pham, MD, MSc

Role: STUDY_CHAIR

University Medical Center Ho Chi Minh City

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Medical Center Ho Chi Minh City

Ho Chi Minh City, , Vietnam

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Vietnam

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Hoang Vu Vu, MD, PhD

Role: CONTACT

Phone: +84908431304

Email: [email protected]

Dang Duy Quang Pham, MD, MSc

Role: CONTACT

Phone: +84937134599

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Hoang Vu Vu, MD, PhD

Role: primary

Dang Duy Quang Pham, MD, MSc

Role: backup

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 34447992 (View on PubMed)

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.

Reference Type RESULT
PMID: 35443059 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

43/2024/HĐ-ĐHYD

Identifier Type: -

Identifier Source: org_study_id