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A multicenter, randomized controlled trial comparing the efficacy and safety of the CARdiac disEase management program CRS-1 with outpatient cardiac REHABilitation in patients with late-phase recovery from cardiovascular disease (J CARE REHAB Study)

A confirmatory trial of the cardiac disease management program CRS-1 in patients with heart failure and related conditions

Terashima Kazuhiro

CaTe Inc.

5F, 5-25-13, Hongo, Bunkyo-ku, Tokyo

crs1device@cate.co.jp

Miyaguchi Yukie

CaTe Inc.

5F, 5-25-13, Hongo, Bunkyo-ku, Tokyo

+81-3-6273-8578

crs1device@cate.co.jp

Recruiting

June. 08, 2026

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

- Patients who meet any of the indications for cardiovascular disease rehabilitation under the Japanese medical fee schedule (effective from June 1, 2026)-chronic heart failure, angina pectoris, after cardiac surgery, great vessel disease, or peripheral arterial occlusive disease-and whom the investigator judges to require cardiovascular disease rehabilitation
- Patients with a 6-minute walk distance of >=200 m and <550 m during the baseline observation period
- Patients eligible for standard outpatient cardiac rehabilitation
- Patients with a level of ICT literacy sufficient to use the investigational device

- Patients for whom exercise therapy is contraindicated, or whom the investigator considers unable to undergo cardiac rehabilitation (including patients with difficulty walking or communicating)
- Patients with any of the following cardiovascular conditions: (i) untreated unstable angina, (ii) uncontrolled arrhythmia, (iii) symptomatic severe aortic stenosis, (iv) uncontrolled symptomatic heart failure (equivalent to NYHA class IV), (v) acute pulmonary embolism or pulmonary infarction, (vi) acute myocarditis or pericarditis, (vii) acute aortic dissection, (viii) end-stage heart failure, (ix) findings suggestive of residual myocardial ischemia, or (x) status post left ventricular assist device implantation
- Patients with acute myocardial infarction with untreated significant stenosis remaining in a major coronary artery
- Patients with severe renal impairment (including those on dialysis) or severe hepatic impairment
- Patients who are pregnant, breastfeeding, or wish to become pregnant during the trial period
- Patients scheduled to undergo therapeutic cardiovascular surgery or intervention, or cardiac transplantation, within 24 weeks after informed consent, or whose life expectancy is estimated to be less than six months at the time of informed consent
- Patients undergoing or scheduled to undergo inpatient cardiac rehabilitation for 28 days or longer at the time of informed consent or at the end of the baseline observation period
- Patients participating in another clinical trial or interventional clinical study
- Patients whom the investigator judges unable to adequately understand the significance of the trial or to comply with its requirements due to cognitive impairment, psychiatric symptoms, or visual or hearing impairment
- Other patients whom the investigator judges to be inappropriate for participation in this trial

Both

Chronic heart failure, angina pectoris,after cardiac surgery, great vessel disease, PAOD

A treatment intervention under remote monitoring-comprising comprehensive cardiac rehabilitation centered on unsupervised exercise therapy using the cardiac disease management program "CRS-1"-or outpatient cardiac rehabilitation as standard treatment is performed for 12 weeks.

Change from baseline in 6-minute walk distance after 84 days of treatment intervention.
The safety evaluation cohort is not subject to the primary endpoint.

1) Secondary endpoints for efficacy
- Change from baseline in cardiopulmonary exercise test (CPX) parameters (Peak VO2, AT, VE/VCO2 slope) after 84 days of treatment intervention
- Change from baseline in quality of life questionnaires (KCCQ, EQ-5D-5L, HADS) after 84 days of treatment intervention
- Continuation rate of exercise therapy during the 84-day treatment period
- Duration and frequency of exercise therapy during the 84-day treatment period
- Adherence rate and success rate of exercise therapy during the 84-day treatment period
- Number of outpatient visits and unscheduled consultations during the 84-day treatment period
- Success rate of exercise prescription during the 84-day treatment period
- Recording rate of vital signs and other data during the 84-day treatment period

2) Secondary endpoints for safety
- Number of adverse events
- Number of cardiovascular events
- All-cause mortality

3) Secondary endpoints for device deficiencies
- Number of deficiencies of the investigational device
- Number of deficiencies of study-use devices other than the investigational device

Nov. 19, 2025

Yes

For the secondary use of anonymized data, relevant laws and regulations (including the Act on the Protection of Personal Information and the Guidelines for the Proper Handling of Medical Information) and applicable ethical guidelines shall be complied with, and re-approval from an ethics review committee may be obtained as necessary. Information disclosure to subjects regarding the purpose of use, scope of use, and recipients of the data shall be considered.

none