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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000046696
Receipt No. 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 2022/01/22

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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
Email 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
Email izawa@fujita-hu.ac.jp

Sponsor
Institute Fujita Health University
Institute
Department

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
Email 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
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 Open public 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 01 Month 22 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053273

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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