Yongin Severance Hospital
Yongin, Gyeonggi-do, 16995, South Korea
Location status: Recruiting
NCT Number: NCT06811519
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.
Interested in participating?
Request Info20 year and older
All sexes
Observational
Yongin, Gyeonggi-do, 16995, South Korea
Location status: Recruiting
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:
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Body Composition Analyzer (ACCUNIQ BC720)
Time frame: within 1 week
Prediction of Left Ventricular Ejection Fraction < 50%
Contact information is provided by the study sponsor or research team.
In Hyun Jung, MD., PhD.
CONTACT
SungA Bae, MD., PhD.
CONTACT
Yonsei University
Other
Acronym: ECHO-FIT
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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