An observational study in Heart Failure, Left Ventricular (LV) Systolic Dysfunction and Body Composition Measurement, sponsored by Yonsei University. Recruiting at 1 site in Korea, Republic of. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-04.
Sponsored by Yonsei University · Observational
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.
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:
Secondary:
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).
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 2,000 is above the median of 200 across 1,983 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Yonsei University is the lead sponsor of 1,418 studies on the registry; 241 are open to participants now.
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This study is conducted in patients who have undergone transthoracic echocardiography.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diagnostic Test: Scanning body composition analyzer and performing AI algorithms
Diagnostic Test: Body Composition Analyzer (ACCUNIQ BC720)
Body Composition Analyzer (ACCUNIQ BC720)
Left Ventricular Ejection Fraction < 50%
Prediction of Left Ventricular Ejection Fraction \< 50%
Time frame: within 1 week
Plan to share: Undecided
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