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Clinical Trials/JPRN-jRCT1052230158
JPRN-jRCT1052230158
Recruiting
未知

An exploratory clinical study of a home detection system for heart failure using a wristwatch-type wearable device and a smartphone application

Miyagawa Shigeru0 sites30 target enrollmentJanuary 9, 2024

Overview

Phase
未知
Intervention
Not specified
Conditions
Chronic Heart Failure
Sponsor
Miyagawa Shigeru
Enrollment
30
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 9, 2024
End Date
TBD
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Miyagawa Shigeru

Eligibility Criteria

Inclusion Criteria

  • 1\) Chronic heart failure patients with ACCF/AHA heart failure stage classification Stage C or D
  • 2\) Patients with NT\-proBNP level higher than 900 pg/ml or BNP lever higher than 200 pg/ml at screening\*
  • (\*: If both are measured, prioritize NT\-proBNP)
  • 3\)Patients aged 18 years or older at the time of informed consent
  • 4\) New York Heart Association (NYHA) class II or higher
  • 5\) Patients who can use equipment (wristwatch type wearable device/smartphone) (completed training)

Exclusion Criteria

  • 1\) Patients who have difficulty being auscultated near the left nipple
  • 2\)Patients who a doctor has judged to have heart failure, mainly in the right heart failure
  • 3\) Patients whose heart sounds cannot be fully confirmed by a doctor's auscultation
  • 4\) For outpatients, patients with a weight gain of 5% or more from the weight (optimal weight) measured around the last day of hospitalization for heart failure.
  • 5\) For outpatients, patients with edema on the front of both lower legs
  • 6\) Other patients who are judged to be inappropriate by the research director (co\-investigator)

Outcomes

Primary Outcomes

Not specified

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