UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000038129
Receipt No. R000043458
Scientific Title Epigenome-wide association study identifies a novel DNA methylation in patients with severe aortic valve stenosis
Date of disclosure of the study information 2019/09/27
Last modified on 2020/05/22 (Ver. 4)

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Basic information
Public title Epigenome-wide association study identifies a novel DNA methylation in patients with severe aortic valve stenosis
Acronym Epigenome-wide association study identifies a novel DNA methylation in patients with severe aortic valve stenosis
Scientific Title Epigenome-wide association study identifies a novel DNA methylation in patients with severe aortic valve stenosis
Scientific Title:Acronym Epigenome-wide association study identifies a novel DNA methylation in patients with severe aortic valve stenosis
Region
Japan

Condition
Condition patient of aortic valve stenosis and health people
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 It remains unknown whether DNA methylation in peripheral blood cells is related to pathogenesis of Aortic Valve Stenosis(AS).
The aim of the present study was to perform an epigenome-wide association study (EWAS) for AS with two different groups (discovery and replicate), to identify AS-specific alterations in DNA methylation in peripheral blood mononuclear cells (PBMC). In addition, the present study evaluated the effects of surgical treatments on the levels of DNA methylation and its related transcription.
Basic objectives2 Others
Basic objectives -Others identify AS-specific alterations in DNA methylation in peripheral blood mononuclear cells.
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes identifies a novel DNA methylation in patients with severe aortic valve stenosis
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Symptomatic AS, An aortic valve area of < 1.0 cm2, An aortic valve area index of < 0.6 cm2/m2, Mean aortic gradient > 40 mmHg or peak aortic velocity > 4 m / second
Key exclusion criteria clinical signs of acute coronary syndrome, acute infection, severe renal failure (serum creatine levels over 3 mg/dL) or rheumatoid disease, or if they were suspected of having a malignant or primary wasting disorder
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Mamoru
Middle name
Last name Satoh
Organization Iwate Medical University
Division name Division of Biomedical Information Analysis, Institute for Biomedical Sciences
Zip code 028-3694
Address 1-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate , Japa
TEL +81-19-613-7111
Email satohm@iwate-med.ac.jp

Public contact
Name of contact person
1st name Takahito
Middle name
Last name Nasu
Organization Iwate Medical University
Division name Division of Biomedical Information Analysis, Institute for Biomedical Sciences
Zip code 028-3694
Address 1-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate , Japan
TEL +81-19-613-7111
Homepage URL
Email tnasu@iwate-med.ac.jp

Sponsor
Institute Iwate Medical University
Institute
Department

Funding Source
Organization AMED
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Ethical Review Board of Iwate Medical University
Address 1-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate , Japan
Tel +81-19-613-7111
Email kenkyu-rinri@j.iwate-med.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
2019 Year 09 Month 27 Day

Related information
URL releasing protocol Under preparation at our university
Publication of results Published

Result
URL related to results and publications https://www.ahajournals.org/doi/10.1161/CIRCGEN.119.002649
Number of participants that the trial has enrolled 188
Results 
 EWAS revealed that DNA methylation of a CpG site differed significantly between the AS group and controls. The DNA methyltion level of chromosome 8 position 126448033, which is located at TRIB1 (tribbles homolog 1), was lower in the AS group than in the controls
Results date posted
2020 Year 05 Month 22 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2020 Year 01 Month 12 Day
Baseline Characteristics 
There were no significant differences in the number of subjects, age and proportion of males between the AS group and controls in both discovery and replication studies.  There were significant differences in blood pressure and lipid profile between the AS group and controls in both discovery and replication studies.  There were significant differences in the prevalence of use of some medications including diuretics, beta-blockers, statins, angiotensin converting enzymes (ACEI), angiotensin receptor blockers (ARB) and calcium channel blockers (CCB) between the discovery and replication studies).
Participant flow 
Peripheral blood was collected from patients with AS for baseline data before surgical treatment and again 12 months after surgical treatment (aortic valve replacement [AVR] or transcatheter aortic valve implantation [TAVI]) and from the controls.
Adverse events 
no
Outcome measures 
deteced CpG site hypomethylation rate
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 04 Month 11 Day
Date of IRB
2014 Year 05 Month 26 Day
Anticipated trial start date
2014 Year 06 Month 01 Day
Last follow-up date
2018 Year 11 Month 30 Day
Date of closure to data entry
2019 Year 03 Month 15 Day
Date trial data considered complete
2019 Year 06 Month 20 Day
Date analysis concluded
2019 Year 09 Month 30 Day

Other
Other related information Currently under analysis by EWAS, unknown

Management information
Registered date
2019 Year 09 Month 27 Day
Last modified on
2020 Year 05 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043458