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

Study Contact Backup

Study Locations

  • Vietnam
      • Ho Chi Minh City, Vietnam, 700000
        • Recruiting
        • University Medical Center Ho Chi Minh City
        • Contact:
        • Contact:
        • 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
Drug: Optimal treatment
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.

Sponsor

University Medical Center Ho Chi Minh City (UMC)

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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