UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	We will identify biomarkers of diastolic dysfunction
Title of the study (Brief title)	We will identify biomarkers of diastolic dysfunction
Region	Japan

Condition
Condition	diastolic dysfunction
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We will identify biomarkers reflecting the disease states of diastolic dysfunction.
Basic objectives2	Others
Basic objectives -Others	We will identify biomarkers reflecting the disease states of contractile dysfunction.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	biomarkers reflecting the disease states of diastolic dysfunction
Key secondary outcomes

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	60 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	heart failure
Key exclusion criteria	myocarditis, cardiac infarction with atrial fibrillation, pacemarker which can not take a magnetic resonance imaging, kidney failure, contrast agent allergy
Target sample size	300

Research contact person
Name of lead principal investigator	Teruo Inoue
Organization	Dokkyo Medical University
Division name	Department of Cardiovascular Medicine
Address	880 Kitakobayashi, Mibu Tochigi, 321-0293, Japan
TEL	0282-86-1111
Email	syo-tky@umin.ac.jp

Public contact
Name of contact person	Syotaro Obi/Masashi Sakuma/Shigeru Toyoda
Organization	Dokkyo Medical University
Division name	Department of Cardiovascular Medicine
Address	880 Kitakobayashi, Mibu Tochigi, 321-0293, Japan
TEL	0282-86-1111
Homepage URL
Email	syo-tky@umin.ac.jp

Sponsor
Institute	Dokkyo Medical University
Institute
Department

Funding Source
Organization	Dokkyo Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	2023 Year 06 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 05 Month 28 Day
Anticipated trial start date	2018 Year 05 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	We will identify biomarkers of diastolic dysfunction from blood of patients with heart failure.

Management information
Registered date	2018 Year 07 Month 05 Day
Last modified on	2018 Year 07 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037689