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Clinical Trials/JPRN-jRCT2052190111
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

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.

Registry
who.int
Start Date
February 20, 2020
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Sawa Yoshiki

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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