Chronic Coronary SyndromeOPPO-WATCHNCT07912671
Out-Patient Proactive Observation With Wearable-Assisted Tracking for Cardiovascular Health Management
A study testing Wearable Device-Based Monitoring and LE8 Feedback and Routine Outpatient Care With Data-Blinded Wearable Monitoring in people with Chronic Coronary Syndrome, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
The goal of this randomized controlled study is to evaluate whether a wearable device-based, Life's Essential 8 (LE8)-guided management strategy can improve cardiovascular health in patients with chronic coronary syndrome (CCS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Coronary Syndrome
- What is being tested?
- Wearable Device-Based Monitoring and LE8 Feedback and Routine Outpatient Care With Data-Blinded Wearable Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2026to 31 Dec 2028
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years.
- Diagnosis of chronic coronary syndrome (CCS) according to the 2024 European Society of Cardiology (ESC) Guidelines for the Management of Chronic Coronary Syndromes.
- Able and willing to provide written informed consent and comply with scheduled study follow-up.
- Owns a smartphone and has sufficient ability to install, log in to, and routinely use the study application.
- Baseline Life's Essential 8 (LE8) cardiovascular health score <80 before randomization.
Who cannot join
- Presence of an indication for coronary revascularization, as determined by the investigator according to the 2024 ESC Guidelines for the Management of Chronic Coronary Syndromes.
- Acute heart failure, hemodynamic instability, or cardiogenic shock.
- ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) within 30 days before enrollment.
- Clinically significant severe arrhythmias, including but not limited to:
- Sustained or paroxysmal ventricular tachycardia or ventricular fibrillation;
- Persistent atrial fibrillation or atrial flutter with inadequate ventricular rate control (resting heart rate >100 beats/min);
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- High-grade or complete atrioventricular block;
- Symptomatic bradycardia or arrhythmias requiring pacemaker support;
- Other serious arrhythmias considered by the investigator to interfere with resting heart rate assessment or compromise participant safety.
- Severe chronic heart failure with left ventricular ejection fraction (LVEF) ≤40%.
- Severe hepatic or renal impairment, including clinically significant severe hepatic dysfunction, diagnosed Child-Pugh class B or C cirrhosis, or other severe hepatic impairment as judged by the investigator; or estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m².
- Malignancy or expected survival <12 months.
- Major bleeding within the previous 3 months, active bleeding, or any history of intracranial hemorrhage.
- Anemia, defined as hemoglobin <120 g/L in men or <110 g/L in women.
- Thyroid disease, unless treated with thyroid hormone replacement and clinically stable for ≥3 months.
- Presence of an implanted pacemaker or implantable cardioverter-defibrillator.
- Participation in another clinical study within the previous 12 months.
- Presence of a high-risk condition related to exercise, a requirement for close medical supervision, or any condition considered by the investigator to make the participant unsuitable for home-based physical activity management or long-term follow-up.
- Bariatric/metabolic surgery within the 12 months before screening, ongoing substantial postoperative weight loss, or planned bariatric/metabolic surgery during the study follow-up period.
- Any other condition considered by the investigator to make the participant unsuitable for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, 100037
About this study
Official title: Wearable Device-Based Long-Term Management of Coronary Artery Disease: The OPPO-WATCH Study
The goal of this randomized controlled study is to evaluate whether a wearable device-based, Life's Essential 8 (LE8)-guided management strategy can improve cardiovascular health in patients with chronic coronary syndrome (CCS).
Approximately 400 participants will be randomly assigned in a 1:1 ratio to either a wearable device-based management group or a data-blinded control group. All participants will receive routine cardiology outpatient follow-up every 3 months for 12 months. Participants in the intervention group will be able to view selected smartwatch data and will receive health and medication reminders as well as individualized LE8 feedback. Participants in the control group will also wear the smartwatch for data collection, but the monitoring data, reminders, and LE8 feedback will not be made available to participants in the control group.
The main question is whether the wearable device-based management strategy results in a greater improvement in the overall LE8 cardiovascular health score from baseline to 12 months compared with routine outpatient management.
Read the detailed description
The OPPO-WATCH study is a single-center, prospective, randomized controlled superiority trial designed to evaluate a wearable device-based cardiovascular health management strategy in adults with chronic coronary syndrome (CCS). The study will enroll approximately 400 participants aged 18 years or older who meet the eligibility criteria and have a baseline Life's Essential 8 (LE8) cardiovascular health score of less than 80.
Before randomization, potentially eligible participants will undergo a 4-week run-in period using a data-blinded smartwatch to obtain baseline data required for LE8 assessment and to evaluate device-wearing adherence. Eligible participants will then be randomly assigned in a 1:1 ratio to the intervention group or control group using stratified block randomization. Randomization is stratified by sex, age, and the number of uncontrolled baseline cardiovascular risk factors.
Participants in the intervention group will have access to selected smartwatch-derived information, including physical activity and sleep data. The accompanying App will collect information on nicotine exposure, diet, and medication use. The system will provide reminders related to physical activity, sedentary behavior, sleep, smoking, diet, and medication use. After outpatient follow-up visits, available wearable data, questionnaire responses, clinical measurements, and laboratory data will be integrated to generate an individualized LE8 cardiovascular health report for the participant.
Participants in the control group will also wear the smartwatch, but the device will be used for data collection without providing monitoring data, health reminders, or LE8 feedback to the participant. Both groups will receive routine cardiology outpatient care, with visits at 3, 6, 9, and 12 months. Follow-up physicians will remain blinded to wearable monitoring data and LE8 reports and will make clinical decisions based on routine clinical information.
The primary outcome is the between-group difference in the change in overall LE8 cardiovascular health score from baseline to 12 months. Secondary and exploratory assessments include individual LE8 component scores, cardiovascular events, heart-rate-related measures, arrhythmia and heart rate variability parameters, medication adherence, quality of life, depressive symptoms, behavioral changes, system usability, and health care resource utilization.
- Conditions
- Chronic Coronary Syndrome
- Being tested
- Wearable Device-Based Monitoring and LE8 Feedback, Routine Outpatient Care With Data-Blinded Wearable Monitoring
- Keywords
- coronary heart disease, Smartwatch, Life's Essential 8, Cardiovascular Health, Digital Health
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable Device-Based Monitoring and LE8 FeedbackDevice
The smartwatch displays monitoring information, including physical activity and sleep data, and continuously uploads collected data to the study platform through encrypted transmission. The accompanying app collects questionnaires on smoking, diet, and medication use, which are verified during follow-up visits. The system provides reminders related to insufficient physical activity, prolonged sedentary time, insufficient sleep, smoking cessation or reduction, diet, and medication use. After each in-person follow-up visit, the system integrates wearable data, questionnaire responses, and clinical measurements to generate an LE8 cardiovascular health score report for the participant, with individualized prompts for components that do not meet target levels. Follow-up physicians remain masked to wearable monitoring data and LE8 reports and provide clinical care and medication adjustments based on routine clinical information.
Routine Outpatient Care With Data-Blinded Wearable MonitoringOther
The smartwatch displays only the time while collecting physical activity and sleep data. Monitoring data are not accessible to participants or follow-up physicians. The accompanying app collects questionnaires on smoking, diet, and medication use, which are verified during follow-up visits. The system does not provide health or medication reminders, scores, or feedback to participants. Collected data are encrypted and uploaded to a blinded backend for outcome assessment and quality control. LE8 scores are calculated automatically and exported for endpoint analysis after follow-up is completed. During routine in-person visits, physicians assess participants using clinical interviews, physical examinations, and necessary ancillary tests, and adjust medications and follow-up management without access to wearable monitoring data or LE8 scores.
| Study group | Role | What they receive |
|---|---|---|
| Wearable Device-Based Management Group | Experimental | Participants receive wearable device-based, LE8-guided management with access to their monitoring data, health and medication reminders, and individualized LE8 score feedback, together with routine in-person cardiology outpatient follow-up every three months for 12 months. Receives: Device: Wearable Device-Based Monitoring and LE8 Feedback |
| Data-Blinded Wearable Monitoring Group | Active comparator | Participants wear a smartwatch for data collection but do not have access to monitoring data, health or medication reminders, or Life's Essential 8 (LE8) score feedback. They receive routine in-person cardiology outpatient follow-up every three months for 12 months. Receives: Other: Routine Outpatient Care With Data-Blinded Wearable Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Life's Essential 8 (LE8) Cardiovascular Health Score
The primary outcome is the between-group difference in the change in the American Heart Association's Life's Essential 8 (LE8) cardiovascular health score from baseline to 12 months. The LE8 score is calculated automatically by the cloud-based system using data on eight cardiovascular health components: physical activity, sleep health, nicotine exposure, diet, blood pressure, blood glucose, blood lipids, and body mass index. Each component is scored from 0 to 100, and the overall LE8 score is calculated as the unweighted average of the eight component scores, ranging from 0 to 100. Higher scores indicate better cardiovascular health.
Measured: From baseline through 12 months
Secondary outcomes (40)
Change in Life's Essential 8 (LE8) Blood Lipids Component Score
The Life's Essential 8 (LE8) Blood Lipids component score is calculated based on non-high-density lipoprotein cholesterol (non-HDL-C), defined as total cholesterol minus high-density lipoprotein cholesterol (HDL-C), according to the predefined LE8 scoring criteria. The component score ranges from 0 to 100 points, with higher scores indicating better cardiovascular health in the blood lipids domain. The outcome is the between-group difference in the change in this component score from baseline to 12 months.
Measured: From baseline through 12 months
Change in Life's Essential 8 (LE8) Blood Glucose Component Score
The Life's Essential 8 (LE8) Blood Glucose component score is calculated based on blood glucose-related measurements according to the predefined LE8 scoring criteria. The component score ranges from 0 to 100 points, with higher scores indicating better cardiovascular health in the blood glucose domain. The outcome is the between-group difference in the change in this component score from baseline to 12 months.
Measured: From baseline through 12 months
Change in Life's Essential 8 (LE8) Blood Pressure Component Score
The Life's Essential 8 (LE8) Blood Pressure component score is calculated based on measured systolic and diastolic blood pressure according to the predefined LE8 scoring criteria. The component score ranges from 0 to 100 points, with higher scores indicating better cardiovascular health in the blood pressure domain. The outcome is the between-group difference in the change in this component score from baseline to 12 months.
Measured: From baseline through 12 months
Change in Life's Essential 8 (LE8) Body Mass Index Component Score
The Life's Essential 8 (LE8) Body Mass Index component score is calculated based on body mass index (BMI), derived from measured height and weight, according to the predefined LE8 scoring criteria. The component score ranges from 0 to 100 points, with higher scores indicating better cardiovascular health in the body mass index domain. The outcome is the between-group difference in the change in this component score from baseline to 12 months.
Measured: From baseline through 12 months
Change in Life's Essential 8 (LE8) Physical Activity Component Score
The Life's Essential 8 (LE8) Physical Activity component score is calculated based on moderate-to-vigorous physical activity (MVPA), measured using the wearable device according to the predefined LE8 scoring criteria. The component score ranges from 0 to 100 points, with higher scores indicating better cardiovascular health in the physical activity domain. The outcome is the between-group difference in the change in this component score from baseline to 12 months.
Measured: From baseline through 12 months
Change in Life's Essential 8 (LE8) Sleep Duration Component Score
The Life's Essential 8 (LE8) Sleep Duration component score is calculated based on sleep duration measured using the wearable device according to the predefined LE8 scoring criteria. The component score ranges from 0 to 100 points, with higher scores indicating better cardiovascular health in the sleep domain. The outcome is the between-group difference in the change in this component score from baseline to 12 months.
Measured: From baseline through 12 months
Change in Life's Essential 8 (LE8) Nicotine Exposure Component Score
The Life's Essential 8 (LE8) Nicotine Exposure component score is calculated based on nicotine exposure assessed using a standardized questionnaire administered through the mobile application according to the predefined LE8 scoring criteria. The component score ranges from 0 to 100 points, with higher scores indicating better cardiovascular health in the nicotine exposure domain. The outcome is the between-group difference in the change in this component score from baseline to 12 months.
Measured: From baseline through 12 months
Change in Life's Essential 8 (LE8) Diet Component Score
The Life's Essential 8 (LE8) Diet component score is calculated based on dietary information collected using a standardized questionnaire administered through the mobile application according to the predefined LE8 scoring criteria. The component score ranges from 0 to 100 points, with higher scores indicating better cardiovascular health in the dietary domain. The outcome is the between-group difference in the change in this component score from baseline to 12 months.
Measured: From baseline through 12 months
LE8 Score ≥80 points
Proportion of participants with a Life's Essential 8 (LE8) cardiovascular health score ≥80 points at 12 months. The LE8 score ranges from 0 to 100, with higher scores indicating better cardiovascular health.
Measured: 12 months
Proportion of Participants With an Increase of ≥5 Points in the Life's Essential 8 (LE8) Cardiovascular Health Score at 12 Months
Cardiovascular health will be assessed using the American Heart Association's Life's Essential 8 (LE8) cardiovascular health score, which ranges from 0 to 100, with higher scores indicating better cardiovascular health. The change in LE8 score will be calculated as the 12-month score minus the baseline score. An improvement is defined as an increase of at least 5 points. The proportion of participants meeting this criterion will be calculated.
Measured: Baseline to 12 months
Proportion of Participants With an Increase of ≥10 Points in the Life's Essential 8 (LE8) Cardiovascular Health Score at 12 Months
Cardiovascular health will be assessed using the American Heart Association's Life's Essential 8 (LE8) cardiovascular health score, which ranges from 0 to 100, with higher scores indicating better cardiovascular health. The change in LE8 score will be calculated as the 12-month score minus the baseline score. An improvement is defined as an increase of at least 10 points. The proportion of participants meeting this criterion will be calculated.
Measured: Baseline to 12 months
Proportion of Participants With an Increase of ≥15 Points in the Life's Essential 8 (LE8) Cardiovascular Health Score at 12 Months
Cardiovascular health will be assessed using the American Heart Association's Life's Essential 8 (LE8) cardiovascular health score, which ranges from 0 to 100, with higher scores indicating better cardiovascular health. The change in LE8 score will be calculated as the 12-month score minus the baseline score. An improvement is defined as an increase of at least 15 points. The proportion of participants meeting this criterion will be calculated.
Measured: Baseline to 12 months
Major Adverse Cardiovascular Events (MACE)
The incidence of the composite endpoint of MACE, including cardiac death, acute myocardial infarction, hospitalization for heart failure, and coronary revascularization.
Measured: From baseline through 12 months
Cardiac death
The incidence of cardiac death.
Measured: From baseline through 12 months
Acute myocardial infarction
The incidence of acute myocardial infarction.
Measured: From baseline through 12 months
Hospitalization for heart failure
The incidence of hospitalization for heart failure.
Measured: From baseline through 12 months
Coronary revascularization
The incidence of coronary revascularization.
Measured: From baseline through 12 months
Incidence of New-onset Diabetes Mellitus
The incidence of newly diagnosed diabetes mellitus during the 12-month follow-up period among participants without diabetes at baseline. New-onset diabetes will be identified based on clinical diagnosis and/or standard diagnostic criteria, including HbA1c ≥6.5%, fasting plasma glucose ≥7.0 mmol/L, or 2-hour plasma glucose ≥11.1 mmol/L during an oral glucose tolerance test. In the absence of unequivocal hyperglycemia, confirmatory testing is required. The incidence will be compared between the two study groups.
Measured: From baseline through 12 months
Incidence of New-onset Hypertension
The incidence of newly diagnosed hypertension during the 12-month follow-up period among participants without hypertension at baseline. New-onset hypertension will be identified based on a documented clinical diagnosis or repeated office blood pressure measurements showing systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg, with confirmation according to applicable clinical guidelines. The incidence will be compared between the two study groups.
Measured: From baseline through 12 months
Daytime Average Heart Rate
Changes in mean heart rate during waking hours (daytime) recorded by 24-hour Holter monitoring. Smartwatch data will be used as a reference for consistency assessment.
Measured: Baseline and 12 months
Nighttime Average Heart Rate
Changes in mean heart rate during sleeping hours (nighttime) recorded by 24-hour Holter monitoring. Smartwatch data will be used as a reference for consistency assessment.
Measured: Baseline and 12 months
24-hour Average Heart Rate
Changes in mean heart rate over the full 24-hour period recorded by Holter monitoring. Smartwatch data will be used as a reference for consistency assessment.
Measured: Baseline and 12 months
Proportion of Participants Achieving Target Resting Heart Rate at 12 Months
Resting heart rate is defined as the 1-minute heart rate measured after at least 5 minutes of continuous rest without apparent physical activity. Resting heart rate will be primarily assessed using 24-hour Holter monitoring performed within 1 week before the 12-month visit. Under investigator supervision in a quiet hospital setting, the start and end of the resting period will be recorded, and the mean of three consecutive 1-minute heart rate measurements obtained after 5 minutes of rest will be used. Target resting heart rate is defined as 55-65 beats per minute. The proportion of participants achieving the target range at 12 months will be compared between the two study groups.
Measured: 12 months
Heart Rate Deceleration Capacity (DC)
Change in heart rate deceleration capacity (DC) from baseline to 12 months, calculated from 24-hour Holter recordings to assess autonomic regulatory function. Changes will be compared between study groups.
Measured: Baseline and 12 months
Heart Rate Acceleration Capacity (AC)
Change in heart rate acceleration capacity (AC) from baseline to 12 months, calculated from 24-hour Holter recordings to assess autonomic regulatory function. Changes will be compared between study groups.
Measured: Baseline and 12 months
Arrhythmia and Electrophysiological Parameters
Changes in arrhythmia and electrophysiological parameters assessed by 24-hour Holter monitoring, including premature ventricular contractions (PVCs), PVC burden, non-sustained ventricular tachycardia (NSVT), significant bradycardia, pauses >2 seconds, second-degree or higher atrioventricular block.
Measured: Baseline and 12 months
Incidence of New-onset Atrial Fibrillation
New-onset AF is defined as the absence of AF evidence on baseline 12-lead ECG and 24-hour Holter, followed by the documentation of an AF episode lasting ≥30 seconds via ECG or Holter during the follow-up period.
Measured: 12 months
Atrial Fibrillation Burden
The percentage of time in atrial fibrillation relative to the total recording time (%) derived from 24-hour Holter monitoring. Assessed at baseline and 12 months.
Measured: Baseline and 12 months
Low-Density Lipoprotein Cholesterol (LDL-C)
Changes in LDL-C levels from baseline to 12 months. Blood samples will be collected at the study site for laboratory analysis.
Measured: Baseline and 12 months
Glycated Hemoglobin (HbA1c)
Changes in HbA1c levels from baseline to 12 months. Blood samples will be collected at the study site for laboratory analysis.
Measured: Baseline and 12 months
Fasting Blood Glucose (FBG)
Changes in FBG levels from baseline to 12 months. Blood samples will be collected at the study site for laboratory analysis.
Measured: Baseline and 12 months
Uric Acid (UA)
Changes in UA levels from baseline to 12 months. Blood samples will be collected at the study site for laboratory analysis.
Measured: Baseline and 12 months
Homocysteine (HCY)
Changes in plasma homocysteine levels from baseline to 12 months. Blood samples will be collected at the study site for laboratory analysis.
Measured: Baseline and 12 months
Changes in Cardiovascular Medication Use
Changes in cardiovascular medication use, including guideline-directed therapies such as antiplatelet agents, lipid-lowering medications, β-blockers, and renin-angiotensin system inhibitors, will be assessed from baseline to 12 months. Changes in the use of each medication class will be compared between the two study groups.
Measured: 12 months
Medication Adherence
Change in medication adherence from baseline to 12 months, assessed using the Adherence to Refills and Medications Scale (ARMS).
Measured: Baseline and 12 months
Change in EQ-5D-5L Index Value
The EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire assesses health in five dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has five response levels, ranging from no problems to extreme problems or inability to perform. Responses across the five dimensions define a health state, which is represented by an EQ-5D-5L index value.
Measured: Baseline and 12 months
Change in EQ Visual Analogue Scale (EQ VAS) Score
The EuroQol Visual Analogue Scale (EQ VAS) is a self-rated measure of overall health status. Scores range from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. Higher scores indicate better perceived health status. The change in EQ VAS score from baseline to 12 months and the between-group difference in score changes will be assessed.
Measured: Baseline and 12 months
Patient Health Questionnaire-9 (PHQ-9) Score
Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a 9-item self-report questionnaire assessing depressive symptoms over the preceding 2 weeks. Each item is scored from 0 to 3, yielding a total score ranging from 0 to 27. Higher total scores indicate more severe depressive symptoms and a worse outcome. The change in PHQ-9 total score from baseline to 12 months and the between-group difference in score changes will be assessed.
Measured: Baseline and 12 months
Blood Pressure Control Rate
The proportion of participants achieving the target blood pressure control (<130/80 mmHg) at 12 months.
Measured: 12 months
Change in Peripheral Oxygen Saturation (SpO₂)
Change in peripheral oxygen saturation (percentage points) from baseline to 12 months.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start30 Nov 2026 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- Guangdong HeyTap Technology Co., Ltd.
- Responsible party
- Principal investigator, Erli Zhang, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07912671
- Sponsor's protocol ID
- FW-ZEL-001
- Acronym
- OPPO-WATCH
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data that underlie the results reported in the primary publication will be made available to qualified researchers upon reasonable request and approval of a methodologically sound research proposal, subject to an appropriate data use agreement.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Device-Based Long-Term Management of Coronary Artery Disease: The OPPO-WATCH Study
- ClinicalTrials.gov ID
- NCT07912671
- Acronym / sponsor ID
- OPPO-WATCH / FW-ZEL-001
- Conditions
- Chronic Coronary Syndrome
- Keywords
- coronary heart disease, Smartwatch, Life's Essential 8, Cardiovascular Health, Digital Health
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Collaborators
- Guangdong HeyTap Technology Co., Ltd.
- Study start
- 30 Nov 2026 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 3 Nov 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.
The goal of this randomized controlled study is to evaluate whether a wearable device-based, Life's Essential 8 (LE8)-guided management strategy can improve cardiovascular health in patients with chronic coronary syndrome (CCS).
Approximately 400 participants will be randomly assigned in a 1:1 ratio to either a wearable device-based management group or a data-blinded control group. All participants will receive routine cardiology outpatient follow-up every 3 months for 12 months. Participants in the intervention group will be able to view selected smartwatch data and will receive health and medication reminders as well as individualized LE8 feedback. Participants in the control group will also wear the smartwatch for data collection, but the monitoring data, reminders, and LE8 feedback will not be made available to participants in the control group.
The main question is whether the wearable device-based management strategy results in a greater improvement in the overall LE8 cardiovascular health score from baseline to 12 months compared with routine outpatient management.
Detailed description
The OPPO-WATCH study is a single-center, prospective, randomized controlled superiority trial designed to evaluate a wearable device-based cardiovascular health management strategy in adults with chronic coronary syndrome (CCS). The study will enroll approximately 400 participants aged 18 years or older who meet the eligibility criteria and have a baseline Life's Essential 8 (LE8) cardiovascular health score of less than 80.
Before randomization, potentially eligible participants will undergo a 4-week run-in period using a data-blinded smartwatch to obtain baseline data required for LE8 assessment and to evaluate device-wearing adherence. Eligible participants will then be randomly assigned in a 1:1 ratio to the intervention group or control group using stratified block randomization. Randomization is stratified by sex, age, and the number of uncontrolled baseline cardiovascular risk factors.
Participants in the intervention group will have access to selected smartwatch-derived information, including physical activity and sleep data. The accompanying App will collect information on nicotine exposure, diet, and medication use. The system will provide reminders related to physical activity, sedentary behavior, sleep, smoking, diet, and medication use. After outpatient follow-up visits, available wearable data, questionnaire responses, clinical measurements, and laboratory data will be integrated to generate an individualized LE8 cardiovascular health report for the participant.
Participants in the control group will also wear the smartwatch, but the device will be used for data collection without providing monitoring data, health reminders, or LE8 feedback to the participant. Both groups will receive routine cardiology outpatient care, with visits at 3, 6, 9, and 12 months. Follow-up physicians will remain blinded to wearable monitoring data and LE8 reports and will make clinical decisions based on routine clinical information.
The primary outcome is the between-group difference in the change in overall LE8 cardiovascular health score from baseline to 12 months. Secondary and exploratory assessments include individual LE8 component scores, cardiovascular events, heart-rate-related measures, arrhythmia and heart rate variability parameters, medication adherence, quality of life, depressive symptoms, behavioral changes, system usability, and health care resource utilization.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wearable Device-Based Management Group | Experimental | Device: Wearable Device-Based Monitoring and LE8 FeedbackParticipants receive wearable device-based, LE8-guided management with access to their monitoring data, health and medication reminders, and individualized LE8 score feedback, together with routine in-person cardiology outpatient follow-up every three months for 12 months. |
| Data-Blinded Wearable Monitoring Group | Active comparator | Other: Routine Outpatient Care With Data-Blinded Wearable MonitoringParticipants wear a smartwatch for data collection but do not have access to monitoring data, health or medication reminders, or Life's Essential 8 (LE8) score feedback. They receive routine in-person cardiology outpatient follow-up every three months for 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years.
- Diagnosis of chronic coronary syndrome (CCS) according to the 2024 European Society of Cardiology (ESC) Guidelines for the Management of Chronic Coronary Syndromes.
- Able and willing to provide written informed consent and comply with scheduled study follow-up.
- Owns a smartphone and has sufficient ability to install, log in to, and routinely use the study application.
- Baseline Life's Essential 8 (LE8) cardiovascular health score <80 before randomization.
Key exclusion criteria (20 listed)
- Presence of an indication for coronary revascularization, as determined by the investigator according to the 2024 ESC Guidelines for the Management of Chronic Coronary Syndromes.
- Acute heart failure, hemodynamic instability, or cardiogenic shock.
- ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) within 30 days before enrollment.
- Clinically significant severe arrhythmias, including but not limited to:
- Severe chronic heart failure with left ventricular ejection fraction (LVEF) ≤40%.
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 |
|---|---|---|
| Wearable Device-Based Monitoring and LE8 FeedbackThe smartwatch displays monitoring information, including physical activity and sleep data, and continuously uploads collected data to the study platform through encrypted transmission. The accompanying app collects questionnaires on smoking, diet, and medication use, which are verified during follow-up visits. The system provides reminders related to insufficient physical activity, prolonged sedentary time, insufficient sleep, smoking cessation or reduction, diet, and medication use. After each in-person follow-up visit, the system integrates wearable data, questionnaire responses, and clinical measurements to generate an LE8 cardiovascular health score report for the participant, with individualized prompts for components that do not meet target levels. Follow-up physicians remain masked to wearable monitoring data and LE8 reports and provide clinical care and medication adjustments based on routine clinical information. | Device | Wearable Device-Based Management Group |
| Routine Outpatient Care With Data-Blinded Wearable MonitoringThe smartwatch displays only the time while collecting physical activity and sleep data. Monitoring data are not accessible to participants or follow-up physicians. The accompanying app collects questionnaires on smoking, diet, and medication use, which are verified during follow-up visits. The system does not provide health or medication reminders, scores, or feedback to participants. Collected data are encrypted and uploaded to a blinded backend for outcome assessment and quality control. LE8 scores are calculated automatically and exported for endpoint analysis after follow-up is completed. During routine in-person visits, physicians assess participants using clinical interviews, physical examinations, and necessary ancillary tests, and adjust medications and follow-up management without access to wearable monitoring data or LE8 scores. | Other | Data-Blinded Wearable Monitoring Group |
Primary outcome
Change in Life's Essential 8 (LE8) Cardiovascular Health Score
Time frame: From baseline through 12 months
The primary outcome is the between-group difference in the change in the American Heart Association's Life's Essential 8 (LE8) cardiovascular health score from baseline to 12 months. The LE8 score is calculated automatically by the cloud-based system using data on eight cardiovascular health components: physical activity, sleep health, nicotine exposure, diet, blood pressure, blood glucose, blood lipids, and body mass index. Each component is scored from 0 to 100, and the overall LE8 score is calculated as the unweighted average of the eight component scores, ranging from 0 to 100. Higher scores indicate better cardiovascular health.
40 secondary outcomes
Change in Life's Essential 8 (LE8) Blood Lipids Component Score
Time frame: From baseline through 12 months
Change in Life's Essential 8 (LE8) Blood Glucose Component Score
Time frame: From baseline through 12 months
Change in Life's Essential 8 (LE8) Blood Pressure Component Score
Time frame: From baseline through 12 months
Change in Life's Essential 8 (LE8) Body Mass Index Component Score
Time frame: From baseline through 12 months
Change in Life's Essential 8 (LE8) Physical Activity Component Score
Time frame: From baseline through 12 months
Change in Life's Essential 8 (LE8) Sleep Duration Component Score
Time frame: From baseline through 12 months
Change in Life's Essential 8 (LE8) Nicotine Exposure Component Score
Time frame: From baseline through 12 months
Change in Life's Essential 8 (LE8) Diet Component Score
Time frame: From baseline through 12 months
LE8 Score ≥80 points
Time frame: 12 months
Proportion of Participants With an Increase of ≥5 Points in the Life's Essential 8 (LE8) Cardiovascular Health Score at 12 Months
Time frame: Baseline to 12 months
Proportion of Participants With an Increase of ≥10 Points in the Life's Essential 8 (LE8) Cardiovascular Health Score at 12 Months
Time frame: Baseline to 12 months
Proportion of Participants With an Increase of ≥15 Points in the Life's Essential 8 (LE8) Cardiovascular Health Score at 12 Months
Time frame: Baseline to 12 months
Major Adverse Cardiovascular Events (MACE)
Time frame: From baseline through 12 months
Cardiac death
Time frame: From baseline through 12 months
Acute myocardial infarction
Time frame: From baseline through 12 months
Hospitalization for heart failure
Time frame: From baseline through 12 months
Coronary revascularization
Time frame: From baseline through 12 months
Incidence of New-onset Diabetes Mellitus
Time frame: From baseline through 12 months
Incidence of New-onset Hypertension
Time frame: From baseline through 12 months
Daytime Average Heart Rate
Time frame: Baseline and 12 months
Nighttime Average Heart Rate
Time frame: Baseline and 12 months
24-hour Average Heart Rate
Time frame: Baseline and 12 months
Proportion of Participants Achieving Target Resting Heart Rate at 12 Months
Time frame: 12 months
Heart Rate Deceleration Capacity (DC)
Time frame: Baseline and 12 months
Heart Rate Acceleration Capacity (AC)
Time frame: Baseline and 12 months
Arrhythmia and Electrophysiological Parameters
Time frame: Baseline and 12 months
Incidence of New-onset Atrial Fibrillation
Time frame: 12 months
Atrial Fibrillation Burden
Time frame: Baseline and 12 months
Low-Density Lipoprotein Cholesterol (LDL-C)
Time frame: Baseline and 12 months
Glycated Hemoglobin (HbA1c)
Time frame: Baseline and 12 months
Fasting Blood Glucose (FBG)
Time frame: Baseline and 12 months
Uric Acid (UA)
Time frame: Baseline and 12 months
Homocysteine (HCY)
Time frame: Baseline and 12 months
Changes in Cardiovascular Medication Use
Time frame: 12 months
Medication Adherence
Time frame: Baseline and 12 months
Change in EQ-5D-5L Index Value
Time frame: Baseline and 12 months
Change in EQ Visual Analogue Scale (EQ VAS) Score
Time frame: Baseline and 12 months
Patient Health Questionnaire-9 (PHQ-9) Score
Time frame: Baseline and 12 months
Blood Pressure Control Rate
Time frame: 12 months
Change in Peripheral Oxygen Saturation (SpO₂)
Time frame: Baseline and 12 months
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 3 Nov 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data that underlie the results reported in the primary publication will be made available to qualified researchers upon reasonable request and approval of a methodologically sound research proposal, subject to an appropriate data use agreement.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable Device-Based Monitoring and LE8 Feedback and Routine Outpatient Care With Data-Blinded Wearable Monitoring in people with Chronic Coronary Syndrome, run by China National Center for Cardiovascular Diseases at 1 site in China.
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 5 inclusion and 20 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 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Contact Erli Zhang (+86 13621010047, zhangerli@fuwaihospital.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Life's Essential 8 (LE8) Cardiovascular Health Score (time frame: From baseline through 12 months). 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 3 Nov 2026.