Congenital Heart Disease (CHD)AUSC-CHDNCT07376785
Can Smartphones Listen to Your Heart? A Performance Study on Detecting Inborn Heart Diseases in Your Heart Sounds
An observational study of Congenital Heart Disease (CHD), run by The University of Hong Kong at 2 sites in Hong Kong.
Trial summary
This observational study aims to assess the performance of the software called ausculto™. ausculto™ is a collection of computer algorithms that intend to analyse heart sounds recorded from the built-in microphone of a smartphone for abnormal sounds. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Congenital Heart Disease (CHD)
- What is being tested?
- Computer algorithms
- How many people
- 220 participants
- Where
- 2 sitesHong Kong
- Study dates
- 26 May 2026to Nov 2026
- 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 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Paediatric and adult hospital patients who have undergone echocardiography within 3 years.
Who may be able to join
- Age: ≥ 6 years
- Have undergone echocardiography within 3 years at their normal non-research hospital attendance
Who cannot join
- Implanted active medical devices in the torso, such as pacemakers and defibrillators
- Have purely non-congenital valvular heart disease
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong2 sites
Queen Mary Hospital
Hong Kong
Hong Kong Children's Hospital
Kowloon Bay
About this study
Official title: Smartphone-Based Use of Phonocardiography for Detection of Congenital Heart Disease: Diagnostic Performance Study
This observational study aims to assess the performance of the software called ausculto™. ausculto™ is a collection of computer algorithms that intend to analyse heart sounds recorded from the built-in microphone of a smartphone for abnormal sounds.
Participants will have their heart sounds recorded during their normal attendance at the hospitals after consenting to participate in this study.
Researchers will manually annotate the recorded heart sounds to create a database for use in future training and testing of artificial intelligence (AI) intended for medical uses.
- Conditions
- Congenital Heart Disease (CHD)
- Being tested
- Computer algorithms
- Keywords
- Smartphone, Mobile Applications, Telemedicine, Heart Defects, Congenital, Phonocardiography, Heart Sounds, Heart Murmurs, Heart Auscultation
- Medical subject headings
- Heart Defects, Congenital, Heart Murmurs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer algorithmsDiagnostic test
Also called ausculto™, Vitogram™
Collection of lightweight computer algorithms called ausculto™ that is designed to perform real-time heart sound analysis to detect heart murmur.
| Study group | Role | What they receive |
|---|---|---|
| Abnormal Echocardiography Diagnosis | Participants with abnormal echocardiography diagnosis within three years. Receives: Diagnostic Test: Computer algorithms | |
| Normal Echocardiography Diagnosis | Participants with normal echocardiography diagnosis within three years. Receives: Diagnostic Test: Computer algorithms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differentiation of Murmurs Associated with Congenital Heart Disease from Normal Heart Sounds and Innocent Murmurs in Heart Sound Recordings
Identification of murmurs associated with congenital heart disease from normal heart sounds and innocent murmurs in recorded heart sounds (phonocardiogram [PCG]), measured in the form of sensitivity and specificity.
Measured: Day 0
Secondary outcomes (2)
Differentiation of Murmurs Associated with Congenital Heart Disease from Normal Heart Sounds and Innocent Murmurs in Heart Sound Recordings
Identification of murmurs associated with congenital heart disease from normal heart sounds and innocent murmurs in recorded heart sounds (phonocardiogram [PCG]), measured in the form of positive and negative predictive value and accuracy.
Measured: Day 0
Number of Adverse Events Reported by Participants or Child Participants' Parent/Legal Guardian During and at the End of Heart Sound Recording That are Determined to be Caused by This Study
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start26 May 2026
- Primary completionSep 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart Disease (CHD)Studies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratory of Data Discovery for Health
- Responsible party
- Principal investigator, Wong Chun Ka, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07376785
- Sponsor's protocol ID
- AUSC-CHD
- Other IDs
- UW 25-328
- Acronym
- AUSC-CHD
- Status last verified
- Jun 2026
- First submitted
- 21 Jan 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Individual data sharing
- No: Data will be considered proprietary.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone-Based Use of Phonocardiography for Detection of Congenital Heart Disease: Diagnostic Performance Study
- ClinicalTrials.gov ID
- NCT07376785
- Acronym / sponsor ID
- AUSC-CHD / AUSC-CHD
- Conditions
- Congenital Heart Disease (CHD)
- Keywords
- Smartphone, Mobile Applications, Telemedicine, Heart Defects, Congenital, Phonocardiography, Heart Sounds, Heart Murmurs, Heart Auscultation
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Laboratory of Data Discovery for Health
- Study start
- 26 May 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 29 Jan 2026 (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 observational study aims to assess the performance of the software called ausculto™. ausculto™ is a collection of computer algorithms that intend to analyse heart sounds recorded from the built-in microphone of a smartphone for abnormal sounds.
Participants will have their heart sounds recorded during their normal attendance at the hospitals after consenting to participate in this study.
Researchers will manually annotate the recorded heart sounds to create a database for use in future training and testing of artificial intelligence (AI) intended for medical uses.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abnormal Echocardiography Diagnosis | – | Diagnostic Test: Computer algorithmsParticipants with abnormal echocardiography diagnosis within three years. |
| Normal Echocardiography Diagnosis | – | Diagnostic Test: Computer algorithmsParticipants with normal echocardiography diagnosis within three years. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Paediatric and adult hospital patients who have undergone echocardiography within 3 years.
Key inclusion criteria (2 listed)
- Age: ≥ 6 years
- Have undergone echocardiography within 3 years at their normal non-research hospital attendance
Key exclusion criteria (2 listed)
- Implanted active medical devices in the torso, such as pacemakers and defibrillators
- Have purely non-congenital valvular heart disease
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 |
|---|---|---|
| Computer algorithmsAlso: ausculto™, Vitogram™Collection of lightweight computer algorithms called ausculto™ that is designed to perform real-time heart sound analysis to detect heart murmur. | Diagnostic test | Abnormal Echocardiography Diagnosis, Normal Echocardiography Diagnosis |
Primary outcome
Differentiation of Murmurs Associated with Congenital Heart Disease from Normal Heart Sounds and Innocent Murmurs in Heart Sound Recordings
Time frame: Day 0
Identification of murmurs associated with congenital heart disease from normal heart sounds and innocent murmurs in recorded heart sounds (phonocardiogram [PCG]), measured in the form of sensitivity and specificity.
2 secondary outcomes
Differentiation of Murmurs Associated with Congenital Heart Disease from Normal Heart Sounds and Innocent Murmurs in Heart Sound Recordings
Time frame: Day 0
Number of Adverse Events Reported by Participants or Child Participants' Parent/Legal Guardian During and at the End of Heart Sound Recording That are Determined to be Caused by This Study
Time frame: Day 0
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 23 Jun 2026.
- Individual participant dataSharing planned: No. Data will be considered proprietary.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease (CHD), run by The University of Hong Kong at 2 sites in Hong Kong.
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 2 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: enrolling by invitation, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differentiation of Murmurs Associated with Congenital Heart Disease from Normal Heart Sounds and Innocent Murmurs in Heart Sound Recordings (time frame: Day 0). 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 23 Jun 2026.