UMIN-CTR Clinical Trial

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
Last 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
1st 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