Remote Monitoring of biological information based on NEMURI SCAN in Patients with Heart Failure Study

Phase 4

Recruiting

• Conditions: Heart failure; heart failure, cardiovascular disease, arrhythmias; D006333

• Registration Number: JPRN-jRCT1032200017
• Lead Sponsor: Kasai Takatoshi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-04-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

1) 20 years of age and older.
2) Heart failure patients who are diagnosed based on the guideline.
3) Written informed consents are obtained by the patients.

Exclusion Criteria

1) Patients who are considered difficult to use or control the device.
2) Patients who are considered difficult to participate the study by their doctors.
3) Patients who use medical devices which are not confirmed as safe about simultaneous use with Nemuri SCAN.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical deterioration events of heart failure defined as each/combined of death, hospitalization, emergency department visits, urgent care visit, and intravenous diuretics due to heart failure.

Secondary Outcome Measures

Name	Time	Method
Each/Combined events of all-cause death, cardiovascular death, and clinical deterioration events of heart failure defined as hospitalization, emergency department visits, urgent care visit, and intravenous diuretics.<br>Clinical improvement of heart failure in hospitalization.<br>Sleep variables of patients underwent in-laboratory polysomnography.<br>Cardiac variables of Holter ECG monitored patients.<br>Rate and reason of data loss and non-use in the remote monitoring.