UMIN-CTR Clinical Trial

Basic information
Public title	Cardiac MRI findings of heart failure with reduced ejection fraction: A meta-analysis
Acronym	Cardiac MRI findings of heart failure with reduced ejection fraction: A meta-analysis
Scientific Title	Cardiac MRI findings of heart failure with reduced ejection fraction: A meta-analysis
Scientific Title:Acronym	Cardiac MRI findings of heart failure with reduced ejection fraction: A meta-analysis
Region	Japan

Condition
Condition	heart failure with reduced ejection fraction
Classification by specialty	Cardiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Although the cardiac MRI finding of heart failure with reduced ejection fraction (HFrEF) has been reported in previous studies, these findings's prevalence and clinical relevance are unclear. This meta-analysis will clarify the prevalence and prognostic value of CMR findings for HFrEF patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Prevalence of abnormalities of CMR findings and impact on the prognosis in HFrEF patients.
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

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	18 years-old <=
Age-upper limit	95 years-old >=
Gender	Male and Female
Key inclusion criteria	Heart failure with ejection fraction
Key exclusion criteria	N/A
Target sample size

Research contact person
Name of lead principal investigator	1st name Shingo Middle name Last name Kato
Organization	Yokohama City University
Division name	Department of Diagnostic Radiology
Zip code	236-0004
Address	3-9, Fukuura, Kanazawaku, Yokohama, Japan
TEL	07026335766
Email	shingo.m12226@gmail.com

Public contact
Name of contact person	1st name Shingo Middle name Last name Kato
Organization	Yokohama City University
Division name	Department of Diagnostic Radiology
Zip code	236-0004
Address	3-9, Fukuura, Kanazawaku, Yokohama, Japan
TEL	07026335766
Homepage URL
Email	shingo.m12226@gmail.com

Sponsor
Institute	Yokohama City University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	None
Address	None
Tel	None
Email	None

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 10 Month 18 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	2022 Year 10 Month 18 Day
Date of IRB	2022 Year 10 Month 18 Day
Anticipated trial start date	2022 Year 10 Month 18 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This meta-analysis will extract the prevalence of abnormalities in CMR findings or myocardial strain in HFrEF patients. In addition, we will integrate the hazard ratio of these findings for predicting adverse events.

Management information
Registered date	2022 Year 10 Month 18 Day
Last modified on	2022 Year 10 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056086