CClinicalTrials.gg
Not yet recruitingNCT06938893Updated Apr 22, 2025

Study on Cardiac Output Evaluation Based on Wearable Monitoring Data

An observational study in Cardiac Output, sponsored by Navy General Hospital, Beijing. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-22.

Sponsored by Navy General Hospital, Beijing · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years and older
Sex
All
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Study 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 device.

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Conditions studied

  • Cardiac Output
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In context

Lead sponsor

Navy General Hospital, Beijing is the lead sponsor of 36 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Target follow-up
1 Month
Patient registry
Yes

Interventions

  • OtherExercise

    Cardiac output (CO) was measured after exercise intervention in patients with normal cardiac function

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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

    Time frame: From enrollment to the end of follow-up at 1 month

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06938893
Lead sponsor
Navy General Hospital, Beijing
Responsible party
Sponsor
First posted
Apr 22, 2025
Start date
Apr 20, 2025 (estimated)
Primary completion
Nov 30, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Apr 22, 2025

Study contacts

Yutao Guo
Contact
zhanghuiay08@sian.com
+86 13683176151

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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