UMIN-CTR Clinical Trial

Basic information
Public title	Study for Evaluating feasibility of Long-term recording for telemonitoring by heart failure Patients at Home
Acronym	SELPH Study
Scientific Title	Study for Evaluating feasibility of Long-term recording for telemonitoring by heart failure Patients at Home
Scientific Title:Acronym	SELPH Study
Region	Japan

Condition
Condition	Heart Failure
Classification by specialty	Medicine in general Cardiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In outpatients with heart failure and patients discharged after heart failure hospitalization, this study aims to investigate the feasibility of home-monitoring using multiple noninvasive devices designed for telemedicine. Patients or their caregivers monitor their health condition every morning. The investigators evaluate the safety and identify issues in this telemonitoring system by collecting the following information up to 6 months: health-related parameters, compliance, measurement condition data transfer status, and adverse events. In addition, the investigators will try to develop an algorithm for predicting the adverse events using parameters collected with the system.
Basic objectives2	Others
Basic objectives -Others	Feasibility
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Measurement compliance for the telemonitoring system, data transfer status, usability score evaluated by a questionnaire, changes in QOL, and other safety issues.
Key secondary outcomes	- The effectiveness of the alert system which is designed to identify the disease deterioration in patients who had adverse events during the study period. - The group differences in measurement compliance, changes in health-related QOL, the sensitivity for identifying the deterioration, and frequency of errors of the alert system between patients with different background status.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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. Adults >= 20 years old 2. Patients who have experienced heart failure hospitalization during the past 1 year 3. Patients with high risk of heart failure deterioration judged by the investigators 4. Patients who can use smartphone/tablet apps and a hand-held electronic stethoscope by themselves or with a help from a caregiver. 5. Patients who are properly informed and consent to participate.
Key exclusion criteria	1. Patients with unstable angina, significant primary valvular heart disease, or severe arrhythmia (atrial fibrillation is not included in the exclusion criteria). 2. Patients with malignancy, severe respiratory disease, severe cerebrovascular disease, or end-stage renal disease. 3. Patients who are inappropriate for the study, judged by the investigators.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Takatoshi Middle name Last name Kasai
Organization	Juntendo University Hospital
Division name	Department of Cardiovascular Biology and Medicine
Zip code	113-8431
Address	3-1-1 Hongo, Bunkyo-ku, Tokyo
TEL	+81-3-3813-3111
Email	kasai-t@mx6.nisiq.net

Public contact
Name of contact person	1st name Takatoshi Middle name Last name Kasai
Organization	Juntendo University Hospital
Division name	Department of Cardiovascular Biology and Medicine
Zip code	113-8431
Address	3-1-1 Hongo, Bunkyo-ku, Tokyo
TEL	+81-3-3813-3111
Homepage URL
Email	kasai-t@mx6.nisiq.net

Sponsor
Institute	Juntendo University
Institute
Department

Funding Source
Organization	Asahi KASEI, Philips Japan
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Asahi KASEI, Philips Japan
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Juntendo University GCP Center
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel	03-5802-1584
Email	kenkyu5858@juntendo.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

Other administrative information
Date of disclosure of the study information	2020 Year 09 Month 10 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	80
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	2020 Year 07 Month 15 Day
Date of IRB	2020 Year 07 Month 31 Day
Anticipated trial start date	2020 Year 09 Month 10 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry	2022 Year 06 Month 30 Day
Date trial data considered complete	2022 Year 08 Month 24 Day
Date analysis concluded	2022 Year 10 Month 26 Day

Other

Other related information

After enrollment and guidance for the usage of devices, patients undergo home-telemonitoring for up to 6 months using the devices in addition to normal clinical practice. These telemonitoring measurements are not used for normal clinical practice. Also, patients undergo questionnaires before and after the study period. The following adverse events will terminate the follow-up, which can be restarted after the event if the patient wishes to continue the study. After the study period, parameters including background information, measurement status, healthcare-related parameters, usability, healthcare-related QOL, other measurements, event information will be analyzed. 1. Non-cardiac death 2. Cardiac death 3. Unexpected hospitalization due to heart failure 4. Unexpected hospitalization due not to heart failure 5. Unexpected ER visit due to heart failure 6. Unexpected ER visit due not to heart failure 7. Acute coronary syndrome 8. Elective coronary revascularization 9. Strokes 10. Increase in the dose of diuretics or use of IV diuretics at an outpatient clinic 11. Clear signs of heart failure deterioration at an outpatient clinic

Management information
Registered date	2020 Year 09 Month 05 Day
Last modified on	2022 Year 11 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047594