A Study on Ability to Detect Early Deterioration of Heart Failure with Respiratory Instability Telemonitoring - Aided by Innovative Tele-Monitoring Environment To Halt Ongoing Deterioration of Heart Failure: ITMETHOD-HF
- Conditions
- Chronic Heart Failure
- Registration Number
- JPRN-UMIN000027060
- Lead Sponsor
- Osaka University Graduate School of Medicine, Cardiovascular surgery
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 18
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method -Days of RSI decrease (less than 20) preceding exacerbation of heart failure -RSI cutoff value -Malfunctions of home telemonitoring -Inter-day variations in RSI