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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Body Composition Measurement; Left Ventricular (LV) Systolic Dysfunction; Artificial Intelligence (AI)
• Intervention / Treatment: Diagnostic test: Body Composition Analyzer (ACCUNIQ BC720)

Detailed Description

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).

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: SungA Bae, MD., PhD.; Phone Number: 01023273578; Email: cardiobsa@yuhs.ac
• Study Contact Backup: Name: In Hyun Jung, MD., PhD.; Email: saveheart@yuhs.ac

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Yongin, Gyeonggi-do, Korea, Republic of, 16995
      • Recruiting
      • Yongin Severance Hospital
      • Contact: SungA Bae; Phone Number: 01023273578; Email: cardiobsa@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Diagnostic Test: Scanning body composition analyzer and performing AI algorithms	Diagnostic test: Body Composition Analyzer (ACCUNIQ BC720); Body Composition Analyzer (ACCUNIQ BC720)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Left Ventricular Ejection Fraction < 50%	Prediction of Left Ventricular Ejection Fraction < 50%	within 1 week

Collaborators and Investigators

• Sponsor: Yonsei University
• Investigators: Principal Investigator: In Hyun Jung, MD., PhD., Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: January 31, 2025
• First Submitted That Met QC Criteria: January 31, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 1, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: heart failure; left ventricular systolic dysfunction
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Murmurs; Heart Failure; Systolic Murmurs
• Other Study ID Numbers: ECHO-FIT

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
• product manufactured in and exported from the U.S.: No