HeartMate App-Based Remote Monitoring for Cardiovascular Risk Factor Management

NCT07721584 | Not Yet Recruiting

• 1 other identifier: 4-2026-0449
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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

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

Keywords

Cardiovascular Diseases; Heart Failure; Coronary Artery Disease; Heart Valve Diseases;; Peripheral Arterial Disease; Cardiac Rehabilitation; Cardiovascular Risk Factor

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 6 weeks (change from baseline to Week 6)

Secondary Outcomes (3)

• Number of Participants With At Least One Adverse Event (AE)

  From randomization through 6 weeks

• Number of Participants With At Least One Serious Adverse Event (SAE)

  From randomization through 6 weeks

• Proportion of Participants Achieving Target Application Usage (>= 80%)

  Over the 6-week intervention period

Other Outcomes (15)

• Change From Baseline in Systolic Blood Pressure at 6 Weeks

  Baseline and 6 weeks

• Change From Baseline in Diastolic Blood Pressure at 6 Weeks

  Baseline and 6 weeks

• Change From Baseline in Total Cholesterol at 6 Weeks

  Baseline and 6 weeks

Study Arms (2)

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.

Device: HeartMate App-Based Remote Cardiac Rehabilitation Program

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.

Device: Usual Care with HeartMate App-Based rPPG Measurement Only

Interventions

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.

Control Group (Usual Care with App-Based Measurement Only)

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.

Intervention Group (HeartMate App-Based Remote Cardiac Rehabilitation)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Able to use a smartphone application

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Failure, Systolic; Coronary Artery Disease; Heart Valve Diseases; Peripheral Arterial Disease; Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Atherosclerosis; Peripheral Vascular Diseases

Central Study Contacts

Chan Joo Lee, Professor

CONTACT

+82-2-2228-8460; zanzu@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-arm parallel-group randomized controlled pilot trial with 1:1 allocation.

Study Record Dates

• First Submitted: July 12, 2026
• First Posted: July 23, 2026
• Study Start: July 14, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share