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HeartMate App-Based Remote Monitoring for Cardiovascular Risk Factor Management

NCT07721584 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-07-23

No results posted yet for this study

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.

Conditions

Interventions

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/lifestyle guidance at least weekly, and the Severance research team reviews monitoring logs at least weekly and handles all medical decisions and adverse events.

DEVICE

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.

Sponsors & Collaborators

  • Yonsei University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-14
Primary Completion
2028-06-30
Completion
2028-08-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07721584 on ClinicalTrials.gov