DevelopmentandApplication of a Single Feature Recognition Model for Heart Failure Based onArtific… (NCT07667452) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
DevelopmentandApplication of a Single Feature Recognition Model for Heart Failure Based onArtificial Intelligence Optimization Algorithms
50 participantsStarted 2026-06-01
Plain-language summary
The goal of this observational study is to develop and validate a single-feature artificial intelligence algorithm based on data from a wearable ECG patch in patients with heart failure (HF). The main question it aims to answer is:
Does the algorithm, using synchronized ECG and accelerometer signals from the patch, achieve accurate detection of heart sounds (S1, S2, and in some patients S3, S4) compared to the Eko CORE500 digital stethoscope in patients with acute exacerbation of HF?
Participants with confirmed HF (NYHA class II-IV) will undergo two 2-minute sessions of simultaneous ECG patch and digital stethoscope recordings, followed by standard 12-lead ECG. Data will be used for algorithm training and validation, with the primary endpoint being the sensitivity and specificity of heart sound detection against the reference device.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years old;
* Body mass index \< 35 kg/m2;
* Diagnosed with heart failure: according to "Chinese Guidelines for Diagnosis and Treatment of Heart Failure 2024", "2021 ESC Guidelines for Diagnosis and Treatment of Acute and Chronic Heart Failure", and "2022 AHA/ACC/HFSA Guidelines for Management of Heart Failure";
* NYHA classification II - IV;
* Able to fully understand the purpose and process of the trial and voluntarily sign the informed consent form.
Exclusion Criteria:
* There are physical disabilities that prevent safe and thorough testing;
* There are open wounds on the chest skin or the skin is allergic to the patches;
* There is a large amount of pericardial effusion, pericardial tamponade, pleural friction rub, pneumothorax, and a large amount of pleural effusion, which may affect data collection;
* The patient has severe comorbidities or unstable condition, which may interfere with data collection during the study period;
* Other situations where the investigator believes the subject is not suitable to participate in this trial, such as those that may increase the risk of the trial, affect the subject's compliance with the protocol, or affect the subject's ability to complete the trial due to physical or psychological diseases or conditions.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Heart sounds include S1 and S2
Timeframe: 10-15 minutes
Trial details
NCT IDNCT07667452
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University