Cardiac OutputNCT06938893
Study on Cardiac Output Evaluation Based on Wearable Monitoring Data
An observational study of Cardiac Output, run by Navy General Hospital, Beijing.
Trial summary
Based on the monitoring data of wearable devices, with cardiac output (CO) as the gold standard, this study intends to develop a non-invasive evaluation model of CO based on wearable data, and optimize the parameters to realize the cardiac capacity detection function in resting and exercise states on the wearable… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Output
- What is being tested?
- Exercise
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2025to 31 Dec 2026
- How long will I take part?
- 1 Month
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Two hundred HF patients with an left ventricular ejection fraction (LVEF) of less than 50% and 100 normal cardiac function subjects with an LVEF of 50% or greater were enrolled
Who may be able to join
- Over 18 years old
- Left ventricular ejection fraction (Left ventricular ejection fraction, LVEF) < 50%(200 subjects)
- Left ventricular ejection fraction (Left ventricular ejection fraction, LVEF) ≥50% (100 subjects)
- Able to use smart phones and operate wearable devices such as wristbands/watches
Who cannot join
- Patients with pacemaker implantation
- No smartphone
- Currently participating in other clinical trials
- Lactating women
- Pregnant Women
- Unable to run and ride due to personal physical and external reasons (subjects participating in the exercise state cardiac output model study)
- Physical examination results in the past year have clear cardiovascular, metabolic, bone and joint related diseases that have exercise risk, or have diseases and related potential health risks confirmed by the self-examination form of physical status before exercise (participants in the exercise state cardiac output model study)
- No informed consent was obtained
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Based on the monitoring data of wearable devices, with cardiac output (CO) as the gold standard, this study intends to develop a non-invasive evaluation model of CO based on wearable data, and optimize the parameters to realize the cardiac capacity detection function in resting and exercise states on the wearable device.
- Conditions
- Cardiac Output
- Being tested
- Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Cardiac output (CO) was measured after exercise intervention in patients with normal cardiac function
What is being measured
The primary outcome is the main question the study is designed to answer.
cardiac output
Taking cardiac function indicators such as cardiac output by echocardiography as the gold standard, using wearable device monitoring data（Photoplethysmographic pulse wave）, the resting state cardiac output artificial intelligence machine learning model was established, and the sensitivity, specificity, positive predictive value, negative predictive value, F1 score, diagnostic efficiency Area Under Curve (AUC), and the sensitivity, specificity, positive predictive value, negative predictive value, F1 score, diagnostic efficiency of the model were calculated. AUC), precision and precision-recall curves were used to evaluate the performance of the model.
Measured: From enrollment to the end of follow-up at 1 month
Secondary outcomes (1)
Heart failure
Heart failure symptoms, acute heart failure episodes, rehospitalization rates, and cardiovascular mortality
Measured: From enrollment to the end of follow-up at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start20 Apr 2025 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac OutputStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Navy General Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938893
- Sponsor's protocol ID
- HZKY-PJ-2024-57
- Status last verified
- Apr 2025
- First submitted
- 17 Jan 2025
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Cardiac Output Evaluation Based on Wearable Monitoring Data
- ClinicalTrials.gov ID
- NCT06938893
- Acronym / sponsor ID
- HZKY-PJ-2024-57
- Conditions
- Cardiac Output
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Navy General Hospital, BeijingUniversity, hospital or other
- Study start
- 20 Apr 2025 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Apr 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.
Based on the monitoring data of wearable devices, with cardiac output (CO) as the gold standard, this study intends to develop a non-invasive evaluation model of CO based on wearable data, and optimize the parameters to realize the cardiac capacity detection function in resting and exercise states on the wearable device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Two hundred HF patients with an left ventricular ejection fraction (LVEF) of less than 50% and 100 normal cardiac function subjects with an LVEF of 50% or greater were enrolled
Key inclusion criteria (4 listed)
- Over 18 years old
- Left ventricular ejection fraction (Left ventricular ejection fraction, LVEF) < 50%(200 subjects)
- Left ventricular ejection fraction (Left ventricular ejection fraction, LVEF) ≥50% (100 subjects)
- Able to use smart phones and operate wearable devices such as wristbands/watches
Key exclusion criteria (8 listed)
- Patients with pacemaker implantation
- No smartphone
- Currently participating in other clinical trials
- Lactating women
- Pregnant Women
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 |
|---|---|---|
| ExerciseCardiac output (CO) was measured after exercise intervention in patients with normal cardiac function | Other | – |
Primary outcome
cardiac output
Time frame: From enrollment to the end of follow-up at 1 month
Taking cardiac function indicators such as cardiac output by echocardiography as the gold standard, using wearable device monitoring data（Photoplethysmographic pulse wave）, the resting state cardiac output artificial intelligence machine learning model was established, and the sensitivity, specificity, positive predictive value, negative predictive value, F1 score, diagnostic efficiency Area Under Curve (AUC), and the sensitivity, specificity, positive predictive value, negative predictive value, F1 score, diagnostic efficiency of the model were calculated. AUC), precision and precision-recall curves were used to evaluate the performance of the model.
1 secondary outcome
Heart failure
Time frame: From enrollment to the end of follow-up at 1 month
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 22 Apr 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Output, run by Navy General Hospital, Beijing.
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 8 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: opening soon, as of the sponsor's last update on 22 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Yutao Guo (+86 13683176151, zhanghuiay08@sian.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cardiac output (time frame: From enrollment to the end of follow-up at 1 month). 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 22 Apr 2025.