NCT06516562

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for all trials

Timeline
25mo left

Started Aug 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Aug 2023Jun 2028

Study Start

First participant enrolled

August 1, 2023

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 24, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

December 6, 2024

Status Verified

December 1, 2024

Enrollment Period

4 years

First QC Date

July 17, 2024

Last Update Submit

December 3, 2024

Conditions

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

Keywords

Patient registryHeart failureProspective Observational StudyDemographicTreatment characteristicsPrognosisMACE

Outcome Measures

Primary Outcomes (2)

  • All-cause mortality

    Death from any cause

    12 months

  • Heart failure rehospitalization

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

    12 months

Secondary Outcomes (2)

  • Major adverse cardiovascular events

    12 months

  • Guideline-directed medical therapy detail

    12 months

Study Arms (1)

Heart failure with reduced or mildly reduced ejection fraction

Drug: Optimal treatment

Interventions

Optimal treatmentDRUG

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

Heart failure with reduced or mildly reduced ejection fraction

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All eligible patients discharged with a diagnosis of heart failure with reduced or mildly reduced ejection fraction.

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Ho Chi Minh City

Ho Chi Minh City, 700000, Vietnam

RECRUITING

Related Publications (2)

  • 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.

    PMID: 34447992RESULT

  • 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.

    PMID: 35443059RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • 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 CHAIR

  • Quang Binh Truong, Professor

    University of Medicine and Pharmacy at Ho Chi Minh City

    STUDY DIRECTOR

  • Hoang Vu Vu, PhD

    University of Medicine and Pharmacy at Ho Chi Minh City

    PRINCIPAL INVESTIGATOR

  • Dang Duy Quang Pham, MD, MSc

    University Medical Center Ho Chi Minh City

    STUDY CHAIR

Central Study Contacts

Hoang Vu Vu, MD, PhD

CONTACT

+84908431304vu.vh@umc.edu.vn

Dang Duy Quang Pham, MD, MSc

CONTACT

+84937134599quang.pdd@umc.edu.vn

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2024

First Posted

July 24, 2024

Study Start

August 1, 2023

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

June 1, 2028

Last Updated

December 6, 2024

Record last verified: 2024-12

Locations

VN(1)