HeartMate App-Based Remote Monitoring for Cardiovascular Risk Factor Management

Sponsor
Yonsei University
Study ID
NCT07721584
Status
Not Yet Recruiting

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Conditions

  • Cardiac Rehabilitation
  • Cardiovascular Diseases
  • Cardiovascular Risk Factor
  • Coronary Artery Disease
  • Heart Failure, Systolic
  • Heart Valve Diseases
  • Peripheral Arterial Disease

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HeartMate App-Based Remote Cardiac Rehabilitation Program — DEVICE
    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/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 — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Jul 23, 2026
Start date
Jul 14, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Intervention Group (HeartMate App-Based Remote Cardiac Rehabilitation)
    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.
  • Placebo Comparator: Control Group (Usual Care with App-Based Measurement Only)
    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.

Primary Outcome Measure

Change from Baseline in 6-Minute Walk Test (6MWT) Distance at 6 Weeks [ Time Frame: Baseline and 6 weeks (change from baseline to Week 6) ]

Central Contacts

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