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NCT Number: NCT06811519

AI-based Prediction of Cardiac Function Using Echocardiography and Body Composition Data (ECHO-FIT Study)

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Yongin Severance Hospital

Yongin, Gyeonggi-do, 16995, South Korea

Location status: Recruiting

Location contact

SungA Bae

CONTACT

[email protected]

01023273578

About this study

Background and Rationale:

Heart failure represents a significant global health burden, characterized by high morbidity and mortality rates. While echocardiography remains the gold standard for heart failure diagnosis and monitoring, providing crucial measurements like left ventricular ejection fraction (LVEF) and diastolic function assessment, its widespread implementation is limited by resource constraints and operator dependency. Bioelectrical impedance analysis (BIA) offers a promising complementary approach, providing rapid and non-invasive assessment of body composition parameters that have shown correlations with cardiovascular outcomes. This study seeks to leverage the potential synergy between echocardiographic findings and body composition data to develop a more accessible screening tool for cardiac dysfunction.

Study Objectives:

  • Primary: To develop and validate a predictive model for left ventricular function by integrating body composition data from the QCCUNIQ BC 720 device with standard echocardiographic parameters.
  • Secondary:
  • To investigate correlations between body composition indices and echocardiographic measurements
  • To evaluate the utility of body composition analysis in identifying high-risk cardiovascular patients
  • To assess the model's potential as a screening tool in resource-limited settings

Methodology:

This single-center, prospective observational study will enroll 2,000 adults (≥20 years) undergoing routine echocardiography, equally divided between those with normal cardiac function (LVEF ≥50%) and heart failure (LVEF <50%). Participants will undergo body composition analysis using the QCCUNIQ BC 720 device within one week of their echocardiogram.

Data Collection and Analysis:

Comprehensive data collection will include standard echocardiographic parameters (LVEF, diastolic function, structural measurements) and detailed body composition analysis (fat mass, skeletal muscle mass, total body water). Statistical analysis will employ both traditional regression methods and advanced machine learning algorithms to develop the predictive model. Model validation will utilize k-fold cross-validation, with performance assessed through standard metrics including sensitivity, specificity, and area under the curve (AUC).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

Body Composition Analyzer (ACCUNIQ BC720)

Diagnostic Test

Body Composition Analyzer (ACCUNIQ BC720)

Primary outcomes

  1. Left Ventricular Ejection Fraction < 50%

    Time frame: within 1 week

    Prediction of Left Ventricular Ejection Fraction < 50%

Study contacts

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

In Hyun Jung, MD., PhD.

CONTACT

[email protected]

SungA Bae, MD., PhD.

CONTACT

[email protected]

01023273578

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Acronym: ECHO-FIT

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Feb 6, 2025
Registry last updated
Mar 4, 2025

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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