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NCT Number: NCT06516562

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Ho Chi Minh City

Ho Chi Minh City, 700000, Vietnam

Location status: Recruiting

Location contact

Cong Thanh Nguyen, MD, MSc

SUB_INVESTIGATOR

Dang Duy Quang Pham, MD, MSc

CONTACT

[email protected]

+84937134599

Dang Duy Quang Pham, MD, MSc

SUB_INVESTIGATOR

Hoang Vu Vu, MD, PhD

CONTACT

[email protected]

+84908431304

Hoang Vu Vu, MD, PhD

PRINCIPAL_INVESTIGATOR

Thanh Hai Nam Phan, MD, MSc

SUB_INVESTIGATOR

Thi Diem Thuy Vo, MD, MSc

SUB_INVESTIGATOR

About this study

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/)

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Optimal treatment

Drug

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

Primary outcomes

  1. All-cause mortality

    Time frame: 12 months

    Death from any cause

  2. Heart failure rehospitalization

    Time frame: 12 months

    Patient rehospitalization due to cardiovascular causes, excluding apparent non-cardiac causes.

Secondary outcomes

  1. Major adverse cardiovascular events

    Time frame: 12 months

    Acute myocardial infarction, stroke or death from any cause

  2. Guideline-directed medical therapy detail

    Time frame: 12 months

    Information regarding guideline-directed medical therapy, including medications used and dose titration over time.

Study contacts

Contact information is provided by the study sponsor or research team.

Dang Duy Quang Pham, MD, MSc

CONTACT

[email protected]

+84937134599

Hoang Vu Vu, MD, PhD

CONTACT

[email protected]

+84908431304

Sponsors and collaborators

Lead sponsor

University Medical Center Ho Chi Minh City (UMC)

Other

Registry information

Acronym: MCR-HF

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Jul 24, 2024
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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