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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041695
Receipt No. R000047594
Scientific Title Study for Evaluating feasibility of Long-term recording for telemonitoring by heart failure Patients at Home
Date of disclosure of the study information 2020/09/10
Last modified on 2020/09/07

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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
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 Preinitiation
Date of protocol fixation
2020 Year 07 Month 15 Day
Date of IRB
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
Date trial data considered complete
Date analysis concluded

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
2020 Year 09 Month 07 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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