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AI-Powered heart scan study aims to set new standards for heart health

NCT ID NCT07292896

Knowledge-focused Sponsor: First Hospital of China Medical University Source: ClinicalTrials.gov ↗

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This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study will measure a specific heart function index in 2,640 healthy adults and people with heart conditions using AI-enhanced 3D ultrasound. The goal is to establish normal ranges and see how this measurement changes in diseases like heart failure and high blood pressure in the lungs. Participants will undergo a non-invasive ultrasound exam, and no treatment is given.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 2,640 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This study enrolls 5 groups (18-79 years) from clinics/community: Healthy Adults: Han Chinese with normal cardiovascular function (vitals, labs, ECG, echo; no structural heart disease/systemic diseases/poor ultrasound). Pulmonary Hypertension: Diagnosed via right heart catheter (mPAP ≥20 mmHg, 2022 ESC/ERS); excluded if with left heart disease, interfering conditions, organ dysfunction, malignancy, or prior pulmonary surgery. Heart Failure: Meets 2022 AHA/ACC/HFSA criteria; excluded if with significant valvular disease. Tricuspid Regurgitation: Echo-confirmed moderate/severe regurgitation; excluded if with interfering pericardial/arrhythmic issues or congenital heart disease/residual lesions. Atrial Septal Defect: Echo/TEE-confirmed secundum defect (untreated or stable ≥3mo post-op); excluded if with complex congenital heart disease. All undergo standardized clinical/echo assessments for cardiac structure/function.

Ages

18 to 79 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Healthy Adults Group Inclusion Criteria: * Participants must meet all of the following criteria to be enrolled: 1. Of Han Chinese ethnicity 2. Aged 18-79 years 3. Normal blood pressure (\< 140/90 mmHg) 4. Normal fasting blood glucose 5. Normal blood lipid levels (triglycerides, total cholesterol, low-density lipoprotein, high-density lipoprotein) 6. Normal complete blood count results (hemoglobin concentration, white blood cell count, red blood cell count, platelet count) 7. Normal liver and renal function (alanine transaminase \< 2× upper limit of normal; normal creatinine and blood urea nitrogen) 8. Normal electrocardiogram results (occasional atrial premature beats may be enrolled at the investigator's discretion) 9. No structural heart disease and normal cardiac function confirmed by echocardiography Exclusion Criteria: Participants will be excluded if they meet any of the following criteria: 1. Clinically significant cardiac valve regurgitation (≥ mild severity) 2. Respiratory diseases: acute or chronic respiratory disorders 3. Endocrine diseases: thyroid disease, diabetes mellitus, hyperaldosteronism, pheochromocytoma, etc. 4. Abnormal liver function (alanine transaminase \> 2× upper limit of normal), abnormal renal function (elevated creatinine beyond normal range), or dyslipidemia (elevated triglycerides, total cholesterol, low-density lipoprotein, or high-density lipoprotein) 5. Other systemic diseases: anemia, malignancy, connective tissue disease, large artery/peripheral vascular diseases (aortic dilation, aortic dissection, coarctation of the aorta, Takayasu arteritis, atherosclerosis), etc. 6. Pregnant or lactating women 7. Professional athletes 8. Poor-quality ultrasound images that cannot support parameter measurement and analysis Pulmonary Hypertension Group Inclusion Criteria: Patients must meet all of the following criteria to be enrolled: 1. Aged 18-79 years 2. Confirmed diagnosis via right heart catheterization: mean pulmonary arterial pressure (mPAP) ≥ 20 mmHg, in accordance with the 2022 ESC/ERS guidelines Exclusion Criteria: Patients will be excluded if they meet any of the following criteria: 1. Unable to complete right heart catheterization or pressure-volume loop assessment 2. Complicated with significant left heart disease (left ventricular ejection fraction \[LVEF\] \< 50%, significant mitral valve disease) 3. Pericardial disease or arrhythmias (e.g., atrial fibrillation) that severely impair right heart function evaluation 4. Poor-quality images that prevent accurate measurement of right atrial or right ventricular parameters 5. Concurrent liver or renal disease 6. Concurrent malignancy 7. History of surgical procedures such as pulmonary endarterectomy or balloon pulmonary angioplasty Heart Failure Group Inclusion Criteria: Patients must meet all of the following criteria to be enrolled: 1. Aged 18-79 years 2. Meets the 2022 AHA/ACC/HFSA diagnostic criteria for heart failure Exclusion Criteria: Patients will be excluded if they meet any of the following criteria: 1.Complicated with significant valvular heart disease (e.g., severe mitral regurgitation, severe tricuspid regurgitation, etc.) Tricuspid Regurgitation Group Inclusion Criteria: Patients must meet all of the following criteria to be enrolled: 1. Moderate or severe primary or secondary tricuspid regurgitation confirmed by echocardiography 2. Aged 18-79 years Exclusion Criteria: Patients will be excluded if they meet any of the following criteria: 1. Pericardial disease or arrhythmias (persistent atrial fibrillation) that interfere with measurements 2. Congenital heart disease or residual lesions after surgical correction Atrial Septal Defect Group Inclusion Criteria: Patients must meet all of the following criteria to be enrolled: 1. Secundum atrial septal defect confirmed by echocardiography or transesophageal echocardiography 2. Patients who have not undergone closure or surgical correction, or stable patients with \> 3 months postoperatively 3. Aged 18-79 years Exclusion Criteria: 1.Complicated with other complex congenital heart diseases.

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Conditions

The condition(s) this trial relates to.

atrial septal defect heart failure pulmonary hypertension tricuspid valve insufficiency

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial septal defect Healthy adults Heart failure Pulmonary hypertension Tricuspid regurgitation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    25 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Anshan Central Hospital

    Anshan, Liaoning, China

  • Ansteel Group General Hospita

    Anshan, Liaoning, China

  • Beijing Chaoyang Hospital, Capital Medical University

    Beijing, China

  • Chaoyang Central Hospital

    Chaoyang, Liaoning, China

  • Chongqing Liangjiang New Area Hospital of Traditional Chinese Medicine

    Chongqing, Chongqing Municipality, China

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, China

  • Huludao Second People's Hospital

    Huludao, Liaoning, China

  • Liaohua Hospital

    Liaoyang, Liaoning, China

  • Shanghai Chest Hospital

    Shanghai, China

  • Shanxi Provincial People's Hospital

    Taiyuan, Shanxi, China

  • Shenzhen People's Hospital

    Shenzhen, Guangdong, China

  • Shijiazhuang People's Hospital

    Shijiazhuang, Hebei, China

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, China

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, China

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110000, China

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, China

  • The Second Affiliated Hospital of Jilin University

    Changchun, Jilin, China

  • The Second Affiliated Hospital of Shaanxi University of Chinese Medicine

    Xianyang, Shaanxi, China

  • The Third Affiliated Hospital of Hebei Medical University

    Shijiazhuang, Hebei, China

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, China

  • West China Hospital，Sichuan University

    Chengdu, Sichuan, China

  • Xiangyang No.1 Peoples Hospital

    Xiangyang, Hubei, China

  • Zhongshan Hospital, Fudan University, Shanghai

    Shanghai, China

  • the Second Hospital of Dalian Medical University

    Dalian, Liaoning, China

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