NCT07721584Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 23 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 12 Jul 2026
- Start date
- 14 Jul 2026
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Yonsei University
- Diseases
- Heart failure, Coronary artery disease
- NCT number
- NCT07721584
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 14 Jul 2026 to the primary completion date, 30 Jun 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Condition or disease making participation in cardiac rehabilitation difficult
- Psychiatric illness, cognitive impairment, or expected poor adherence that may affect study participation
Other
- Judged unable to undergo PPG measurement
- Atrial fibrillation
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.