UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044423 |
|---|---|
| Receipt number | R000050737 |
| Scientific Title | Development of an Algorithm for Predicting Exacerbation of Heart Failure by Remote Monitoring |
| Date of disclosure of the study information | 2021/06/15 |
| Last modified on | 2021/06/04 07:36:46 |
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Basic information
Public title
Development of an Algorithm for Predicting Exacerbation of Heart Failure by Remote Monitoring
Acronym
Development of an Algorithm for Predicting Exacerbation of Heart Failure by Remote Monitoring
Scientific Title
Development of an Algorithm for Predicting Exacerbation of Heart Failure by Remote Monitoring
Scientific Title:Acronym
Development of an Algorithm for Predicting Exacerbation of Heart Failure by Remote Monitoring
Region
| Japan |
Condition
Condition
heart failure
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to prospectively collect telemonitoring data of patients hospitalized for acute heart failure or acute exacerbation of chronic heart failure at home after discharge, and to develop and evaluate a model to predict the occurrence of heart failure exacerbation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Prediction accuracy of composite cardiac events during telemonitoring period
(1) Rehospitalization due to worsening heart failure, (2) Unscheduled outpatient visit due to worsening heart failure, (3) Outpatient intravenous infusion treatment due to worsening heart failure, (4) Cardiac death
Key secondary outcomes
Prediction accuracy of composite events during telemonitoring period
(1) All unplanned readmissions excluding trauma, (2) Readmissions due to worsening heart failure, (3) Unscheduled outpatient visits due to worsening heart failure, (4) Outpatient intravenous therapy due to worsening heart failure, (5) Cardiac death
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
The telemonitoring period will be about 6 months, and data will be obtained daily from telemonitoring devices at home after discharge.
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
Patients who are judged to meet all of the following criteria are eligible.
(1) Patients admitted to the hospital for acute heart failure or acute exacerbation of chronic heart failure, who have improved with treatment and are scheduled for discharge, or patients within 30 days of discharge.
(2) Patients who meet the following criteria on admission: BNP 100 pg/ml or higher or NT-proBNP 300 pg/mL or higher.
(3) Patients aged 20 years or older
Key exclusion criteria
Patients who are judged to be in conflict with any of the following criteria will be excluded.
(1) Patients who have or will have medical devices such as pacemakers, ICDs, CRT-D, etc.
(2) Patients who are scheduled to undergo PCI or CABG
(3) Patients with a limited prognosis due to irreversible factors such as malignancy.
(4) Patients with obvious cognitive impairment.
(5) Patients who are pregnant or wish to become pregnant during the study period
(6) Patients on maintenance dialysis
(7) Patients who are judged to be difficult or dangerous to ride the weight scale due to limb disabilities, etc.
(8) Patients who cannot be contacted by telephone.
(9) Patients who written consent cannot be obtained.
(10) Other patients who are judged by the doctor in charge to be inappropriate for this study.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Yamaguchi |
Organization
Ehime university graduate school of medicine
Division name
Department of Cardiology, Pulmonology, Hypertension and Nephrology
Zip code
791-0295
Address
Shitsukawa, Toon, Ehime
TEL
089-960-5303
osamu7@gmail.com
Public contact
Name of contact person
| 1st name | Shigehiro |
| Middle name | |
| Last name | Miyazaki |
Organization
Ehime university graduate school of medicine
Division name
Department of Cardiology, Pulmonology, Hypertension and Nephrology
Zip code
791-0295
Address
Shitsukawa, Toon, Ehime
TEL
089-960-5303
Homepage URL
shigehiro.miyazaki.0123@gmail.com
Sponsor or person
Institute
Ehime University Medical School Hospital
Institute
Department
Personal name
Funding Source
Organization
Canon Medical Systems Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ehime University Medical School Hospital
Address
Shitsukawa, Toon, Ehime
Tel
089-960-5914
cttc@m.ehime-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
愛媛大学医学部附属病院（愛媛県）、市立八幡浜病院（愛媛県）、県立今治病院（愛媛県）、市立宇和島病院（愛媛県）、西条中央病院（愛媛県）、喜多医師会病院（愛媛県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 15 | 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
| 2021 | Year | 04 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 04 | Day |
Last modified on
| 2021 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050737
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