[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648515":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":26,"responsibleParty":37,"collaborators":26,"id":39,"slug":40,"hasResults":41,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":26,"eligibilityCriteria":45,"healthyVolunteers":41,"sex":46,"minAge":47,"maxAge":26,"enrollmentInfo":48,"targetDuration":26,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":63,"overallStatus":66,"whyStopped":26,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":26},{"fullName":5,"class":6},"Yonsei University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Group (HeartMate App-Based Remote Cardiac Rehabilitation)","EXPERIMENTAL","Participants use the HeartMate app-based remote cardiac rehabilitation program for 6 weeks (daily rPPG heart check; aerobic and resistance exercise; breathing training; cognitive-behavioral mind program), with at least weekly remote coaching.",[13],"Device: HeartMate App-Based Remote Cardiac Rehabilitation Program",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group (Usual Care with App-Based Measurement Only)","PLACEBO_COMPARATOR","Participants receive usual outpatient follow-up and lifestyle education materials. The HeartMate app is installed for rPPG-based measurement only (no exercise or mind program) to keep digital-biomarker measurement identical across groups.",[19],"Device: Usual Care with HeartMate App-Based rPPG Measurement Only",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","HeartMate App-Based Remote Cardiac Rehabilitation Program","A 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\u002Flifestyle guidance at least weekly, and the Severance research team reviews monitoring logs at least weekly and handles all medical decisions and adverse events.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Usual Care with HeartMate App-Based rPPG Measurement Only","Standard 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.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Chan Joo Lee, Professor","CONTACT","+82-2-2228-8460","zanzu@yuhs.ac",{"type":38,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100648515","heartmate-app-based-remote-monitoring-for-cardiovascular-risk-factor-management-100648515",false,"NCT07721584","HeartMate App-Based Remote Monitoring for Cardiovascular Risk Factor Management","Effect of HeartMate Application-Based Remote Patient Monitoring on Cardiovascular Risk Factor Management: An Exploratory Randomized Controlled Pilot Study","Inclusion Criteria:\n\n1. Adults aged 19 years or older\n2. Patients with cardiac disease judged to require cardiac rehabilitation (e.g., heart failure, valvular heart disease, coronary artery disease, peripheral arterial disease)\n3. Able to be followed for at least 6 weeks during the study period\n4. Able to consent to blood testing and PPG measurement at baseline and endpoint\n5. Able to use a smartphone application\n\nExclusion Criteria:\n\n1. Judged unable to undergo PPG measurement\n2. Atrial fibrillation\n3. Condition or disease making participation in cardiac rehabilitation difficult\n4. Psychiatric illness, cognitive impairment, or expected poor adherence that may affect study participation","ALL","19 Years",{"count":49,"type":50},200,"ESTIMATED","INTERVENTIONAL",[53],"NA","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.",[56,57,58,59,60,61,62],"Cardiovascular Diseases","Heart Failure, Systolic","Coronary Artery Disease","Heart Valve Diseases","Peripheral Arterial Disease","Cardiac Rehabilitation","Cardiovascular Risk Factor",[56,64,58,65,60,61,62],"Heart Failure","Heart Valve Diseases;","NOT_YET_RECRUITING","2026-07-22",{"date":69,"type":70},"2026-07-23","ACTUAL",{"date":72,"type":50},"2026-07-14",{"date":74,"type":50},"2028-08-31",{"name":5,"class":6}]