JPRN-jRCT2052190111
Active, not recruiting
Phase 3
sefulness of Innovative Home Tele-Monitoring Environment Guided by Respiratory Stability Time to prevent Readmissions of Heart Failure Patients
Sawa Yoshiki0 sites80 target enrollmentFebruary 20, 2020
ConditionsChronic heart failure
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Chronic heart failure
- Sponsor
- Sawa Yoshiki
- Enrollment
- 80
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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