UMIN-CTR Clinical Trial

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
Last 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
Email	miyagawa@surg1.med.osaka-u.ac.jp

Public contact
1st 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
Email	m-sakoda@surg1.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University Graduate School of Medicine, Cardiovascular surgery
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031001