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The study of safety and effectiveness of home-based cardiac rehabilitation using digital therapeutics device (Harufit Cardio DTx)

A Multi-Center, Single-Blind, Randomized-Controlled, Parallel, Pivotal Study to Evaluate the safety and efficacy of Harufit Cardio DTx used to improve cardiopulmonary exercise function in subjects requiring cardiac rehabilitation eligible for home-based cardiac rehabilitation

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CRIS
Registry ID
KCT0010349
Enrollment
80
Registered
2025-03-28
Start date
2025-04-04
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others(Harufit Cardio DTx) : 1)Experimental group : HBCR using mobile app The investigator will install Harufit Cardio DTx on the subject's smartphone, sign up, and enter basic information (gender,

Sponsors

Chonnam National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Age 19 to 90 years old 2) Patients with cardiovascular disease who are capable of home-based cardiac rehabilitation 3) Those who are eligible for cardiac rehabilitation[14] ? Patients who have been hospitalized for acute myocardial infarction (I21) or unstable angina (I20) (medication, coronary intervention, etc.) ? Patients who have undergone cardiac surgery such as coronary artery bypass grafting, heart valve surgery, heart transplantation (Z95, Z94.1, I34, I35, I36, I37) ? Compensated heart failure, advanced heart failure (I50) ? Patients who have had surgery to implant a pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy (CRT), or left ventricular assistive device (LVAD) (Z95) ? Patients with atrial or ventricular arrhythmias controlled by medication, ventricular fibrillation or cardiac arrest (I44, I45, I46, I47, I48, I49) ? Patients who have undergone intervention or surgery for peripheral arterial disease (such as lower extremity arteries, aortic aneurysms and dissections) (I73) ? Patients who are at high risk for cardiovascular disease but for various reasons find it difficult to exercise at an appropriate level (C38, I42, I43) ? Patients who have undergone surgery and medication for congenital heart disease (Q20, Q21, Q22, Q23, Q24, Q25, Q26, Q27, Q28) ? Patients who have undergone major lung surgery (pneumonectomy, lobectomy) with expected right ventricular failure (C34, I27, I28) [15] 8th Korean Standardized Classification of Diseases (KCD) 4) Able to walk independently without orthosis 5) Voluntary written consent to participate in this study 6) Able to use a smartphone 7) Smartphone users who can connect with Harufit Cardio DTx

Exclusion criteria

Exclusion criteria: 1) If you are a contraindication for cardiac rehabilitation (Contraindications: unstable angina symptoms, acute myocardial infarction (within 2 days), uncontrolled ventricular arrhythmia, third degree atrioventricular block without a pacemaker, acute congestive heart failure, severe aortic stenosis, acute systemic illness, thrombophlebitis or intracardiac thrombus, active or suspected acute myocarditis, acute pericarditis) 2) Psychiatric illness that makes cooperation difficult 3) High risk according to American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) guidelines (AACVPR Stratification Algorithm for Risk of Event) Patient is at HIGH RISK if ANY ONE OR MORE of the following factors are present: - Left ventricular ejection fraction 6/min] multiform PVCs) at rest or with exercise - MI or cardiac surgery complicated by cardiogenic shock, CHF, and/or signs/symptoms of post-procedure ischemia - Abnormal hemodynamics with exercise, especially flat or decreasing systolic blood pressure or chronotropic incompetence with increasing workload - Significant silent ischemia (ST depression 2mm or greater without symptoms) with exercise or in recovery - Signs/symptoms including angina pectoris, dizziness, lightheadedness or dyspnea at low levels of exercise (< 5.0 METs) or in recovery - Maximal functional capacity less than 5.0 METs* * If measured functional capacity is not available, this variable can be excluded from the risk stratification process. - Clinically significant depression or depressive symptoms 4) Poor knowledge of the Korean language 5) Any other condition that, in the opinion of the investigator, makes it difficult for the subject to participate in the study.

Design outcomes

Primary

MeasureTime frame
VO2max

Secondary

MeasureTime frame
cardiopulmonary function index : METs(Metabolic Equivalent) ;HRrest(Heart rate rest);HRmax(Heart rate max);SBPrest(Systolic Blood Pressure rest);DBPrest(Diastolic Blood Pressure rest);SBPmax(Systolic Blood Pressure max);DBPmax(Diastolic Blood Pressure max);EQ-5D-5L(European Quality of Life Five Dimension);PHQ9(Patient Health Questionnaire-9);KASI(Korea Activity scale and index);Weight;BMI(Body Mass Index)

Countries

Korea, Republic of

Contacts

Public ContactYu Hae Young

Chonnam National University Hospital

154kg@naver.com+82-62-220-5186

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026