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)

未提供0 个研究点目标入组 190 人开始时间: 待定

适应症

试验速览

阶段: 不适用
状态: 招募中
入组人数: 190

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Randomized

入排标准

年龄范围: 18age old over 至 No limit（—）
性别: All

入选标准

•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

排除标准

•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

研究者

发起方

未提供

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