UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027060 |
|---|---|
| Receipt number | R000031001 |
| Scientific Title | 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 - |
| Date of disclosure of the study information | 2017/05/08 |
| Last modified on | 2019/05/02 19:55:49 |
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Basic information
Public title
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 -
Acronym
ITMETHOD-HF
Scientific Title
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 -
Scientific Title:Acronym
ITMETHOD-HF
Region
| Japan |
Condition
Condition
Chronic Heart Failure
Classification by specialty
| Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate that calculated Respiratory Stability Index (RSI) with remote monitoring in patients with chronic heart failure detects earlier deterioration of heart failure.
Basic objectives2
Others
Basic objectives -Others
Usefullness of RSI as an early detection index
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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.
Key secondary outcomes
-Days of RSI decrease (less than 20) preceding exacerbation of heart failure
-RSI cutoff value
-Malfunctions of home telemonitoring
-Inter-day variations in RSI
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
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) ]
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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
Key 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
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shigeru |
| Middle name | |
| Last name | Miyagawa |
Organization
Osaka University Graduate School of Medicine
Division name
Cardiovascular surgery
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka
TEL
06-6879-3154
miyagawa@surg1.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Mika |
| Middle name | |
| Last name | Sakoda |
Organization
Osaka University Graduate School of Medicine
Division name
Cardiovascular surgery
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka
TEL
06-6879-3154
Homepage URL
m-sakoda@surg1.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine, Cardiovascular surgery
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Clinical Research Review Committee
Address
2-2 Yamadaoka, Suita, Osaka 565-0871 Japan
Tel
06-6210-8296
rinri@hp-crc.med.osaka-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
大阪大学医学部附属病院（大阪府）、射水市民病院（富山県）、JCHO高岡ふしき病院（富山県）、田附興風会医学研究所 北野病院（大阪府）、のぞみハートクリニック（東京都）、三重大学医学部附属病院（三重県）、ゆみのハートクリニック（大阪府）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
18
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 26 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 19 | Day |
Last modified on
| 2019 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031001
