Demographic, Clinical, Biological, Treatment Characteristics and Cardiovascular Events of Patients With Heart Failure in Vietnam: a Multicenter Prospective Observational Study (MCR-HF)
December 3, 2024 updated by: University Medical Center Ho Chi Minh City (UMC)
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
2500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hoang Vu Vu, MD, PhD
- Phone Number: +84908431304
- Email: vu.vh@umc.edu.vn
Study Contact Backup
- Name: Dang Duy Quang Pham, MD, MSc
- Phone Number: +84937134599
- Email: quang.pdd@umc.edu.vn
Study Locations
-
-
-
Ho Chi Minh City, Vietnam, 700000
- Recruiting
- University Medical Center Ho Chi Minh City
-
Contact:
- Hoang Vu Vu, MD, PhD
- Phone Number: +84908431304
- Email: vu.vh@umc.edu.vn
-
Contact:
- Dang Duy Quang Pham, MD, MSc
- Phone Number: +84937134599
- Email: quang.pdd@umc.edu.vn
-
Sub-Investigator:
- Cong Thanh Nguyen, MD, MSc
-
Sub-Investigator:
- Thanh Hai Nam Phan, MD, MSc
-
Sub-Investigator:
- Thi Diem Thuy Vo, MD, MSc
-
Sub-Investigator:
- Dang Duy Quang Pham, MD, MSc
-
Principal Investigator:
- Hoang Vu Vu, MD, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
All eligible patients discharged with a diagnosis of heart failure with reduced or mildly reduced ejection fraction.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Heart failure with reduced or mildly reduced ejection fraction
|
Optimal treatment using current National Guidelines for the diagnosis and treatment of chronic heart failure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
All-cause mortality
Time Frame: 12 months
|
Death from any cause
|
12 months
|
|
Heart failure rehospitalization
Time Frame: 12 months
|
Patient rehospitalization due to cardiovascular causes, excluding apparent non-cardiac causes.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Major adverse cardiovascular events
Time Frame: 12 months
|
Acute myocardial infarction, stroke or death from any cause
|
12 months
|
|
Guideline-directed medical therapy detail
Time Frame: 12 months
|
Information regarding guideline-directed medical therapy, including medications used and dose titration over time.
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Cong Thanh Nguyen, MD, MSc, University Medical Center Ho Chi Minh City
- Study Chair: Thanh Hai Nam Phan, MD, MSc, University Medical Center Ho Chi Minh City
- Study Director: Quang Binh Truong, Professor, University of Medicine and Pharmacy at Ho Chi Minh City
- Principal Investigator: Hoang Vu Vu, PhD, University of Medicine and Pharmacy at Ho Chi Minh City
- Study Chair: Dang Duy Quang Pham, MD, MSc, University Medical Center Ho Chi Minh City
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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 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. Erratum In: Eur Heart J. 2021 Dec 21;42(48):4901. doi: 10.1093/eurheartj/ehab670.
- 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. Erratum In: Eur Heart J. 2023 Mar 21;44(12):1057. doi: 10.1093/eurheartj/ehad059.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2023
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
June 1, 2028
Study Registration Dates
First Submitted
July 17, 2024
First Submitted That Met QC Criteria
July 17, 2024
First Posted (Actual)
July 24, 2024
Study Record Updates
Last Update Posted (Estimated)
December 6, 2024
Last Update Submitted That Met QC Criteria
December 3, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 43/2024/HĐ-ĐHYD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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