Clinical Trial

HeartMate App-Based Remote Monitoring for Cardiovascular Risk Factor Management

Not Yet Recruiting
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Summary
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.
Trial Details
NCT Number NCT07721584
Lead Sponsor Yonsei University
Conditions Cardiovascular Diseases, Heart Failure, Systolic, Coronary Artery Disease, Heart Valve Diseases, Peripheral Arterial Disease, Cardiac Rehabilitation, Cardiovascular Risk Factor
Enrollment 200 participants
Start Date 2026-07-14
Primary Completion 2028-06-30 (estimated)
Study Completion 2028-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-23