Heart FailureECHO-FITNCT06811519
AI-based Prediction of Cardiac Function Using Echocardiography and Body Composition Data (ECHO-FIT Study)
An observational study of Heart Failure and Left Ventricular (LV) Systolic Dysfunction, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Left Ventricular (LV) Systolic Dysfunction, Body Composition Measurement
- What is being tested?
- Body Composition Analyzer (ACCUNIQ BC720)
- How many people
- 2,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Feb 2025to 31 Dec 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study is conducted in patients who have undergone transthoracic echocardiography.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
In Hyun Jung, MD., PhD. contact
South Korea1 site, 1 recruiting
- Recruiting
Yongin Severance Hospital
Yongin, Gyeonggi-do, 16995
SungA Bae, 01023273578, cardiobsa@yuhs.ac
About this 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.
Read more
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.
Read the 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).
- Conditions
- Heart Failure, Left Ventricular (LV) Systolic Dysfunction, Body Composition Measurement, Artificial Intelligence (AI)
- Being tested
- Body Composition Analyzer (ACCUNIQ BC720)
- Keywords
- heart failure, left ventricular systolic dysfunction
- Medical subject headings
- Heart Failure, Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body Composition Analyzer (ACCUNIQ BC720)Diagnostic test
Body Composition Analyzer (ACCUNIQ BC720)
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic Test: Scanning body composition analyzer and performing AI algorithms | Diagnostic Test: Scanning body composition analyzer and performing AI algorithms Receives: Diagnostic Test: Body Composition Analyzer (ACCUNIQ BC720) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Ejection Fraction < 50%
Prediction of Left Ventricular Ejection Fraction < 50%
Measured: within 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start24 Feb 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In Hyun Jung, Yonsei University
- Investigators
- In Hyun Jung, MD., PhD., Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06811519
- Sponsor's protocol ID
- ECHO-FIT
- Acronym
- ECHO-FIT
- Status last verified
- Mar 2025
- First submitted
- 31 Jan 2025
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AI-based Prediction of Cardiac Function Using Echocardiography and Body Composition Data (ECHO-FIT Study)
- ClinicalTrials.gov ID
- NCT06811519
- Acronym / sponsor ID
- ECHO-FIT / ECHO-FIT
- Conditions
- Heart Failure, Left Ventricular (LV) Systolic Dysfunction, Body Composition Measurement, Artificial Intelligence (AI)
- Keywords
- heart failure, left ventricular systolic dysfunction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic Test: Scanning body composition analyzer and performing AI algorithms | – | Diagnostic Test: Body Composition Analyzer (ACCUNIQ BC720)Diagnostic Test: Scanning body composition analyzer and performing AI algorithms |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study is conducted in patients who have undergone transthoracic echocardiography.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Body Composition Analyzer (ACCUNIQ BC720)Body Composition Analyzer (ACCUNIQ BC720) | Diagnostic test | Diagnostic Test: Scanning body composition analyzer and performing AI algorithms |
Primary outcome
Left Ventricular Ejection Fraction < 50%
Time frame: within 1 week
Prediction of Left Ventricular Ejection Fraction < 50%
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
In Hyun Jung, MD., PhD. contact
In Hyun Jung, MD., PhD. principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Left Ventricular (LV) Systolic Dysfunction, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SungA Bae, MD., PhD. (01023273578, cardiobsa@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left Ventricular Ejection Fraction < 50% (time frame: within 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025; AzTrials last refreshed its copy on 26 Oct 2026.