This exploratory pilot randomized controlled trial evaluates whether a HeartMate application-based remote patient monitoring (RPM) and digital cardiac rehabilitation program improves cardiovascular, functional, and psychological outcomes in patients with cardiac disease. A total of 200 participants with cardiovascluar disease requiring rehabilitation are randomly assigned in a 1:1 ratio to an intervention group or a control group. The intervention group uses the HeartMate app-based remote cardiac rehabilitation program for 6 weeks, including a daily heart check using smartphone remote photoplethysmography (rPPG), aerobic and resistance exercise, breathing training, and a cognitive-behavioral 'mind' program, with weekly remote coaching. The control group receives usual outpatient care and lifestyle education materials, with the app installed only for rPPG measurement so that digital-biomarker measurement is identical across groups. Clinical assessments (6-minute walk distance, grip strength, blood pressure, blood lipids and metabolic markers), questionnaires (SF-12, PHQ-9, GAD-7, KOSS-24), and digital biomarkers (rPPG-derived heart rate, heart rate variability, respiration, activity) are collected at baseline and at 6 weeks. The primary outcome is the between-group difference in the change in 6-minute walk distance from baseline to 6 weeks. Because this is an exploratory pilot, the results are intended to estimate the effect size and variance for a future definitive randomized controlled trial, and to assess the validity of digital biomarkers as well as the safety, feasibility, and adherence of the program.
Adults aged 19 years or older
Patients with cardiac disease judged to require cardiac rehabilitation (e.g., heart failure, valvular heart disease, coronary artery disease, peripheral arterial disease)
Able to be followed for at least 6 weeks during the study period
Able to consent to blood testing and PPG measurement at baseline and endpoint
Judged unable to undergo PPG measurement
Atrial fibrillation
Condition or disease making participation in cardiac rehabilitation difficult
Psychiatric illness, cognitive impairment, or expected poor adherence that may affect study participation
Parallel
HeartMate App-Based Remote Cardiac Rehabilitation Program
DeviceA 6-week smartphone application program delivering a daily heart check using remote photoplethysmography (rPPG), aerobic and resistance exercise, breathing training, and a cognitive-behavioral mind program. Trained staff provide message-based counseling and exercise/lifestyle guidance at least weekly, and the Severance research team reviews monitoring logs at least weekly and handles all medical decisions and adverse events.
Usual Care with HeartMate App-Based rPPG Measurement Only
DeviceStandard outpatient follow-up and lifestyle education materials without the exercise or mind program. The HeartMate app is installed solely for rPPG-based digital-biomarker measurement at baseline and at 6 weeks, ensuring identical measurement conditions across groups.
Change from Baseline in 6-Minute Walk Test (6MWT) Distance at 6 Weeks
The distance walked (in meters) during the 6-minute walk test, measured at baseline and at 6 weeks. The change (Week 6 minus baseline) is compared between the intervention and control groups. As an exploratory pilot outcome, the primary purpose is to estimate the effect size and standard deviation for a future randomized controlled trial rather than to confirm efficacy.
Number of Participants With At Least One Adverse Event (AE)
Number of participants with at least one adverse event during the intervention period. Unit of measure: participants (count).
Number of Participants With At Least One Serious Adverse Event (SAE)
Number of participants with at least one serious adverse event during the intervention period. Unit of measure: participants (count).
Proportion of Participants Achieving Target Application Usage (>= 80%)
Percentage of intervention-group participants whose HeartMate application usage reaches at least 80% of the prescribed daily sessions. Unit of measure: percentage of participants (%). A higher value indicates better adherence.
Change From Baseline in Systolic Blood Pressure at 6 Weeks
Change from baseline to 6 weeks in resting systolic blood pressure, measured after 5 minutes of rest using an automated sphygmomanometer. Unit of measure: mmHg.
Change From Baseline in Diastolic Blood Pressure at 6 Weeks
Change from baseline to 6 weeks in resting diastolic blood pressure, measured after 5 minutes of rest using an automated sphygmomanometer. Unit of measure: mmHg.
Change From Baseline in Total Cholesterol at 6 Weeks
Change from baseline to 6 weeks in serum total cholesterol. Unit of measure: mg/dL.
Change From Baseline in LDL Cholesterol at 6 Weeks
Change from baseline to 6 weeks in serum low-density lipoprotein (LDL) cholesterol. Unit of measure: mg/dL.
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