UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041695 |
|---|---|
| Receipt number | 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 | 2022/11/09 01:21:35 |
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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
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
kasai-t@mx6.nisiq.net
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047594
