Chronic Heart Failure
Conditions
Interventions
To collect parameters using ITMETHOD remote monitoring system with noninvasive pressure sensor sheet and calculate RSI under home environment [ Time Frame: Intervention period (48 weeks) ]
Sponsors
Osaka University Graduate School of Medicine, Cardiovascular surgery
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with chronic heart failure under treatment (Including patients after heart transplantation or myoblast cell-sheet transplantation) 2. New York Heart Association (NYHA) class II, III and IV 3. Patients must have been hospitalized within 12 months or treated with increases in dose and/or changes in medications for exacerbation of heart failure. 4. Regular visits to our trial sites or affiliated hospitals 5. Daily internet access available in patients' bedrooms 6. Patients with 20 years of age or older at the time of their written consent 7. Patients who provided written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients who share a bed with other person or pets 2. Patients who are not considered able to measure overnight respiratory due to physical factors or lifestyle factors 3. Patients without spontaneous respiration 4. Patients with chronic respiratory failure or chronic obstructive pulmonary disease 5. Patients must not have started to use CPAP or ASV during sleep within a month 6. Patients whose QOL is limited by malignant tumor or other diseases 7. Patients who have sequela as the result of cerebrovascular disorder 8. Patients diagnosed with dementia 9. Patients who are inability to provide informed consent or doubted for his/her agreement 10. Any other patients who are determined as unsuitable for this study by the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity of RSI RSI levels of subjects clinically diagnosed as worsening heart failure by the investigator is decreased (1 day or more that the RSI is less than 20) prior to exacerbation. Specificity of RSI RSI levels of subjects clinically diagnosed stable heart failure by the investigator is not decreased less than 20 on the judgment day. | — |
Secondary
| Measure | Time frame |
|---|---|
| -Days of RSI decrease (less than 20) preceding exacerbation of heart failure -RSI cutoff value -Malfunctions of home telemonitoring -Inter-day variations in RSI | — |
Countries
Japan
Contacts
Public ContactMika Sakoda
Osaka University Graduate School of Medicine Cardiovascular surgery
Outcome results
None listed