UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036328 |
|---|---|
| Receipt number | R000041390 |
| Scientific Title | The Clinical Study of Omics with Plasma and Urine in Chronic Heart Failure Patients: The Investigation with Peripheral Blood |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2019/03/28 14:00:43 |
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Basic information
Public title
The Clinical Study of Omics with Plasma and Urine in Chronic Heart Failure Patients: The Investigation with Peripheral Blood
Acronym
The Clinical Study of Omics with Plasma and Urine in CHF Patients: The Investigation with Peripheral Blood
Scientific Title
The Clinical Study of Omics with Plasma and Urine in Chronic Heart Failure Patients: The Investigation with Peripheral Blood
Scientific Title:Acronym
The Clinical Study of Omics with Plasma and Urine in CHF Patients: The Investigation with Peripheral Blood
Region
| Japan |
Condition
Condition
Cardiovascular disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To explore novel biomarkers which are useful for diagnosis, treatment, and prevention of chronic heart failure.
Basic objectives2
Others
Basic objectives -Others
Novel biomarkers based on the omics analysis.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Genetic rare variant, single nucleotide polymorphism, metabolite, protein, and micro RNA.
Key secondary outcomes
Clinical information (sex, age, height, body weight, blood pressure, heart rate, SAS, NYHA class, HF stage class, heart disease, echocardiogram, blood test, urine test, chest X-ray, electrocardiogram, drug allergy, past history, smoking, drinking, family history).
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
Patients with or at high risk of chronic heart failure those attending Department of Cardiovascular Medicine, Tohoku University Hospital.
Key exclusion criteria
Patients who were judged to be not eligible in the present study by the physician in charge.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiko |
| Middle name | |
| Last name | Sakata |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
980-8574
Address
1-1, Seiryomachi, Aoba-ku, Sendai, Japan
TEL
022(717)7153
sakatayk@cardio.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhiko |
| Middle name | |
| Last name | Sakata |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
980-8574
Address
1-1, Seiryomachi, Aoba-ku, Sendai, Japan
TEL
022(717)7153
Homepage URL
sakatayk@cardio.med.tohoku.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan), The Agency for Medical Research and Development (AMED), and/or unrestricted research grants
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Ethics Committee of Tohoku University Graduate School of Medicine
Address
1-1, Seiryomachi, Aoba-ku, Sendai, Japan
Tel
022(728)4105
med-kenkyo@grp.tohoku.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
東北大学（宮城県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 04 | Month | 01 | 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
759
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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study. Patients with or at high risk of chronic heart failure those attending Department of Cardiovascular Medicine, Tohoku University Hospital.
Management information
Registered date
| 2019 | Year | 03 | Month | 28 | Day |
Last modified on
| 2019 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041390
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
