An exploratory clinical study using a wearable device and smartphone application for heart failure

Not Applicable

Recruiting

• Conditions: Chronic Heart Failure; Chronic heart failure

• Registration Number: JPRN-jRCT1052230158
• Lead Sponsor: Miyagawa Shigeru

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-09
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy, sensitivity, and specificity by algorithm-derived diagnostic results when referring to positive changes ( greater than 30% increase compared to basal NT-proBNP is considered positive change) in NT-proBNP at a hospital visit.