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Development of an Algorithm for Predicting Exacerbation of Heart Failure by Remote Monitoring

Development of an Algorithm for Predicting Exacerbation of Heart Failure by Remote Monitoring - Development of an Algorithm for Predicting Exacerbation of Heart Failure by Remote Monitoring

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000044423
Enrollment
300
Registered
2021-06-15
Start date
2021-06-15
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

heart failure

Interventions

The telemonitoring period will be about 6 months, and data will be obtained daily from telemonitoring devices at home after discharge.

Sponsors

Ehime University Medical School Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients who are judged to meet all of the following criteria are eligible. (1) Patients admitted to the hospital for acute heart failure or acute exacerbation of chronic heart failure, who have improved with treatment and are scheduled for discharge, or patients within 30 days of discharge. (2) Patients who meet the following criteria on admission: BNP 100 pg/ml or higher or NT-proBNP 300 pg/mL or higher. (3) Patients aged 20 years or older

Exclusion criteria

Exclusion criteria: Patients who are judged to be in conflict with any of the following criteria will be excluded. (1) Patients who have or will have medical devices such as pacemakers, ICDs, CRT-D, etc. (2) Patients who are scheduled to undergo PCI or CABG (3) Patients with a limited prognosis due to irreversible factors such as malignancy. (4) Patients with obvious cognitive impairment. (5) Patients who are pregnant or wish to become pregnant during the study period (6) Patients on maintenance dialysis (7) Patients who are judged to be difficult or dangerous to ride the weight scale due to limb disabilities, etc. (8) Patients who cannot be contacted by telephone. (9) Patients who written consent cannot be obtained. (10) Other patients who are judged by the doctor in charge to be inappropriate for this study.

Design outcomes

Primary

MeasureTime frame
Prediction accuracy of composite cardiac events during telemonitoring period (1) Rehospitalization due to worsening heart failure, (2) Unscheduled outpatient visit due to worsening heart failure, (3) Outpatient intravenous infusion treatment due to worsening heart failure, (4) Cardiac death

Secondary

MeasureTime frame
Prediction accuracy of composite events during telemonitoring period (1) All unplanned readmissions excluding trauma, (2) Readmissions due to worsening heart failure, (3) Unscheduled outpatient visits due to worsening heart failure, (4) Outpatient intravenous therapy due to worsening heart failure, (5) Cardiac death

Countries

Japan

Contacts

Public ContactShigehiro Miyazaki

Ehime university graduate school of medicine Department of Cardiology, Pulmonology, Hypertension and Nephrology

shigehiro.miyazaki.0123@gmail.com089-960-5303

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026