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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036328
Receipt No. 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

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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
Email 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
Email sakatayk@cardio.med.tohoku.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Tohoku University Graduate School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041390

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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