UMIN-CTR Clinical Trial

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

Contact us.