Study on Cardiac Output Evaluation Based on Wearable Monitoring Data

April 14, 2025 updated by: Navy General Hospital, Beijing
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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of follow-up at 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart failure
Time Frame: From enrollment to the end of follow-up at 1 month
Heart failure symptoms, acute heart failure episodes, rehospitalization rates, and cardiovascular mortality
From enrollment to the end of follow-up at 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Navy General Hospital, Beijing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 20, 2025

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 17, 2025

First Submitted That Met QC Criteria

April 14, 2025

First Posted (Actual)

April 22, 2025

Study Record Updates

Last Update Posted (Actual)

April 22, 2025

Last Update Submitted That Met QC Criteria

April 14, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • HZKY-PJ-2024-57

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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