NCT06811519

Brief Summary

This prospective observational study (ECHO-FIT Study) aims to develop and validate a predictive model for cardiac function, particularly left ventricular ejection fraction (LVEF), by integrating echocardiographic measurements with body composition data obtained from the QCCUNIQ BC 720 device. The study plans to enroll 2,000 adult participants, comprising 1,000 individuals with normal LVEF (≥50%) and 1,000 with heart failure (LVEF \<50%), all of whom will undergo standard-of-care echocardiography and body composition analysis. By analyzing the relationships between key echocardiographic parameters (such as LVEF and diastolic function) and body composition measures (including fat mass, skeletal muscle mass, and total body water), we will develop a non-invasive prediction model capable of identifying individuals at higher risk of cardiac dysfunction. This innovative approach has the potential to enhance early detection and personalized management of heart failure, reduce dependence on resource-intensive diagnostic procedures, and ultimately improve patient outcomes.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Feb 2025

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

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Study Timeline

Key milestones and dates

Study Progress31%
Feb 2025Dec 2028

First Submitted

Initial submission to the registry

January 31, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 6, 2025

Completed
18 days until next milestone

Study Start

First participant enrolled

February 24, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

March 4, 2025

Status Verified

March 1, 2025

Enrollment Period

2.8 years

First QC Date

January 31, 2025

Last Update Submit

March 1, 2025

Conditions

Keywords

heart failureleft ventricular systolic dysfunction

Outcome Measures

Primary Outcomes (1)

  • Left Ventricular Ejection Fraction < 50%

    Prediction of Left Ventricular Ejection Fraction \< 50%

    within 1 week

Study Arms (1)

Diagnostic Test: Scanning body composition analyzer and performing AI algorithms

Diagnostic Test: Scanning body composition analyzer and performing AI algorithms

Diagnostic Test: Body Composition Analyzer (ACCUNIQ BC720)

Interventions

Body Composition Analyzer (ACCUNIQ BC720)

Diagnostic Test: Scanning body composition analyzer and performing AI algorithms

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study is conducted in patients who have undergone transthoracic echocardiography.

You may qualify if:

  • Aged 20 years or older.
  • Undergoing a standard echocardiographic examination.
  • Providing consent to undergo body composition analysis.
  • Signing the informed consent form to voluntarily participate in the study.

You may not qualify if:

  • Having a physical or mental condition that makes it impossible to conduct an echocardiogram or perform body composition analysis.
  • Deemed inappropriate for study participation by the researcher (e.g., unable to cooperate).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yongin Severance Hospital

Yongin, Gyeonggi-do, 16995, South Korea

RECRUITING

MeSH Terms

Conditions

Heart FailureVentricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVentricular Dysfunction

Study Officials

  • In Hyun Jung, MD., PhD.

    Severance Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

SungA Bae, MD., PhD.

CONTACT

In Hyun Jung, MD., PhD.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 31, 2025

First Posted

February 6, 2025

Study Start

February 24, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

March 4, 2025

Record last verified: 2025-03

Locations