Heart FailureMCR-HFNCT06516562
Demographic, Clinical, Biological, Treatment Characteristics and Cardiovascular Events of Patients With Heart Failure in Vietnam: a Multicenter Prospective Observational Study
An observational study of Heart Failure and Heart Failure With Reduced Ejection Fraction, run by University Medical Center Ho Chi Minh City (UMC) at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Heart Failure With Reduced Ejection Fraction, Heart Failure With Mid Range Ejection Fraction
- What is being tested?
- Optimal treatment
- How many people
- 2,500 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Aug 2023to 1 Jun 2028
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: All eligible patients discharged with a diagnosis of heart failure with reduced or mildly reduced ejection fraction.
Who may be able to join
- 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%
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
University Medical Center Ho Chi Minh City
Ho Chi Minh City, 700000
Hoang Vu Vu, MD, PhD, +84908431304, vu.vh@umc.edu.vn
Dang Duy Quang Pham, MD, MSc, +84937134599, quang.pdd@umc.edu.vn
About this study
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.
Read the 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/)
- Conditions
- Heart Failure, Heart Failure With Reduced Ejection Fraction, Heart Failure With Mid Range Ejection Fraction
- Being tested
- Optimal treatment
- Keywords
- Patient registry, Heart failure, Prospective Observational Study, Demographic, Treatment characteristics, Prognosis, MACE
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimal treatmentDrug
Optimal treatment using current National Guidelines for the diagnosis and treatment of chronic heart failure
| Study group | Role | What they receive |
|---|---|---|
| Heart failure with reduced or mildly reduced ejection fraction | Not described Receives: Drug: Optimal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Death from any cause
Measured: 12 months
Heart failure rehospitalization
Patient rehospitalization due to cardiovascular causes, excluding apparent non-cardiac causes.
Measured: 12 months
Secondary outcomes (2)
Major adverse cardiovascular events
Acute myocardial infarction, stroke or death from any cause
Measured: 12 months
Guideline-directed medical therapy detail
Information regarding guideline-directed medical therapy, including medications used and dose titration over time.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start1 Aug 2023
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University Medical Center Ho Chi Minh City (UMC)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cong Thanh Nguyen, MD, MSc, Study chair, University Medical Center Ho Chi Minh CityThanh Hai Nam Phan, MD, MSc, Study chair, University Medical Center Ho Chi Minh CityQuang Binh Truong, Professor, Study director, University of Medicine and Pharmacy at Ho Chi Minh CityHoang Vu Vu, PhD, Principal investigator, University of Medicine and Pharmacy at Ho Chi Minh CityDang Duy Quang Pham, MD, MSc, Study chair, University Medical Center Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516562
- Sponsor's protocol ID
- 43/2024/HĐ-ĐHYD
- Acronym
- MCR-HF
- Status last verified
- Dec 2024
- First submitted
- 17 Jul 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 34447992Aktaa 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.
PubMed 35443059
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Demographic, Clinical, Biological, Treatment Characteristics and Cardiovascular Events of Patients With Heart Failure in Vietnam: a Multicenter Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06516562
- Acronym / sponsor ID
- MCR-HF / 43/2024/HĐ-ĐHYD
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- University Medical Center Ho Chi Minh City (UMC)University, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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/)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart failure with reduced or mildly reduced ejection fraction | – | Drug: Optimal treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All eligible patients discharged with a diagnosis of heart failure with reduced or mildly reduced ejection fraction.
Key inclusion criteria (3 listed)
- 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%
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optimal treatmentOptimal treatment using current National Guidelines for the diagnosis and treatment of chronic heart failure | Drug | Heart failure with reduced or mildly reduced ejection fraction |
Primary outcome
All-cause mortality
Time frame: 12 months
Death from any cause
Heart failure rehospitalization
Time frame: 12 months
Patient rehospitalization due to cardiovascular causes, excluding apparent non-cardiac causes.
2 secondary outcomes
Major adverse cardiovascular events
Time frame: 12 months
Guideline-directed medical therapy detail
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Results publication: PubMed 34447992McDonagh 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.
- Results publication: PubMed 35443059Aktaa 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cong Thanh Nguyen, MD, MSc study chair
University Medical Center Ho Chi Minh City
Thanh Hai Nam Phan, MD, MSc study chair
University Medical Center Ho Chi Minh City
Quang Binh Truong, Professor study director
University of Medicine and Pharmacy at Ho Chi Minh City
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Heart Failure With Reduced Ejection Fraction, run by University Medical Center Ho Chi Minh City (UMC) at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hoang Vu Vu, MD, PhD (+84908431304, vu.vh@umc.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06516562, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.