UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046696 |
|---|---|
| Receipt number | R000053273 |
| Scientific Title | Prediction of development and severity of heart failure by machine learning of heart rate variability analysis index |
| Date of disclosure of the study information | 2022/01/22 |
| Last modified on | 2022/07/24 17:20:48 |
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Basic information
Public title
Prediction of development and severity of heart failure by machine learning of Holter ECG test
Acronym
HFHRV
Scientific Title
Prediction of development and severity of heart failure by machine learning of heart rate variability analysis index
Scientific Title:Acronym
HFHRV
Region
| Japan |
Condition
Condition
Heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to develop a model to predict the onset, recurrence, and severity of heart failure by adding indicators related to sleep apnea, unstable respiratory control, and heart rate fragmentation to the conventional heart rate variability indicators of Holter ECG, and verify the accuracy of the model by machine learning.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cardiac death or heart failure admission
Key secondary outcomes
decrease in left ventricular ejection fraction [LVEF] to 35% or less, all cause death, cardiac death, heart failure admission
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. Outpatients or stable inpatients at our hospital with left ventricular systolic dysfunction
2. Outpatients or stable inpatients at our hospital with chronic heart failure in sinus rhythm
3. Outpatients or stable inpatients at our hospital with chronic heart failure in atrial fibrillation
Key exclusion criteria
Patients who did not give consent for this study, or patients deemed inappropriate by the principal investigator or sub-investigator
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Hideo |
| Middle name | |
| Last name | Izawa |
Organization
Fujita Health University School of Medicine
Division name
Department of Cardiology
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi
TEL
0562-93-2312
izawa@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Hideo |
| Middle name | |
| Last name | Izawa |
Organization
Fujita Health University
Division name
Department of Cardiology
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi
TEL
0562-93-2312
Homepage URL
izawa@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Suzuken Memorial Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita Health University
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi
Tel
0562-93-2000
f-irb@fujita-hu.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
| 2022 | Year | 01 | Month | 22 | 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
500
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observations included death or heart failure readmission, new appearance of atrial fibrillation, and reduction of left ventricular ejection fraction to 35%.
Management information
Registered date
| 2022 | Year | 01 | Month | 22 | Day |
Last modified on
| 2022 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053273
