sefulness of Innovative Home Tele-Monitoring Environment Guided by Respiratory Stability Time to prevent Readmissions of Heart Failure Patients

Sawa Yoshiki0 个研究点目标入组 80 人开始时间: 2020年2月20日最近更新: 2023年10月17日

适应症

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•1) Patients who provided written informed consent to participate this trial.
•2) Patients must be 20 years of age or older when obtaining their consents.
•3) Patients who have been diagnosed with heart failure according to the Guideline for Diagnosis and Treatment of Acute and Chronic Heart Failure (JCS2017/JHFS2017)
•4) Patients with a history of hospitalization due to worsening heart failure more than once within five years before obtaining their consents.
•5) Patients who can visit outpatient department.
•6) Patients with New York Heart Association Functional Classification of II, III or IV.

•1) Patients who may sleep with another person or pets in the same bed.
•2) Patients who may not sleep more than two hours at night for more than three days a week regularly on their bed due to factors such as lifestyle.
•3) Patients who are unable to breathe on their own.
•4) Patients with chronic obstructive pulmonary disease.
•5) Patients on the supportive ventilation therapy such as Adaptive Servo-Ventilation or continuous Positive Airway Pressure during the night.
•6) Patients who are pregnant.
•7) Patients who do not use highly effective contraception during the run-in period.
•8) Patients with obstructive sleep apnea syndrome as a major disease.
•9) Patients with sequelae due to cerebrovascular disease.
•10) Patients on dialysis due to renal failure.
•11) Patients with severe deterioration in kidney or liver function.
•12) Patients who have been participating in other intervention studies including clinical trials.
•13) Patients with dementia.
•14) Patients with inability to provide informed consent.
•15) Patients who may not be followed-up during run-in period (52 weeks).
•16) Patients who are judged to be inappropriate for this trial by investigators.

发起方

Sawa Yoshiki