UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038129 |
|---|---|
| Receipt number | 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 13:46:57 |
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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
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
tnasu@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043458
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