Clinical trial NCT06811519: AI-based Prediction of Cardiac Function Using Echocardiography and Body Composition Data (ECHO-FIT Study)
Official title: AI-based Prediction of Cardiac Function Using Echocardiography and Body Composition Data (ECHO-FIT Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Left Ventricular (LV) Systolic Dysfunction
Body Composition Measurement
Artificial Intelligence (AI)
Keywords: heart failure
left ventricular systolic dysfunction
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 2000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is conducted in patients who have undergone transthoracic echocardiography.

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.

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).

Eligibility criteria: 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).

Primary outcomes:
measure: Left Ventricular Ejection Fraction < 50%
timeFrame: within 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Yongin
country: Korea, Republic of
facility: Yongin Severance Hospital
state: Gyeonggi-do
Study officials:
affiliation: Severance Hospital
name: In Hyun Jung, MD., PhD.
role: PRINCIPAL_INVESTIGATOR
References: