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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014375
Receipt No. R000016733
Scientific Title Exploratory research for role of typical protein-bound uremic toxins as a cardiorenal syndrome in patients with acute heart failure and/or acute myocardial infarction.
Date of disclosure of the study information 2014/07/01
Last modified on 2016/12/26

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Basic information
Public title Exploratory research for role of typical protein-bound uremic toxins as a cardiorenal syndrome in patients with acute heart failure and/or acute myocardial infarction.
Acronym TUTORIAL-1 trail
Scientific Title Exploratory research for role of typical protein-bound uremic toxins as a cardiorenal syndrome in patients with acute heart failure and/or acute myocardial infarction.
Scientific Title:Acronym TUTORIAL-1 trail
Region
Japan

Condition
Condition acute heart failure and/or acute myocardial infarction
Classification by specialty
Cardiology Nephrology Emergency medicine
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We measure a sequence of blood concentration of typical protein-bound uremic toxins(indoxyl sulfate and p-cresyl sulfate) in patients with acute heart failure and/or acute myocardial infarction.
Basic objectives2 Others
Basic objectives -Others We explore the role of indoxyl sulfate and p-cresyl sulfate as a cardiorenal syndrome in patients with acute heart failure and/or acute myocardial infarction.
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes A sequence of blood concentration of typical protein-bound uremic toxins(indoxyl sulfate and p-cresyl sulfate)
Key secondary outcomes exploratory investigation of relationship between uremic toxins and clinical events after 1 year, physical condition, and other measurements such as renal diameter, laboratory data and so on

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 1. Patient with acute heart failure and/or acute myocardial infarction who had required urgent hospitalization.

2. Over 20 years old patient, regardless of sex.
Key exclusion criteria 1. Patient who was administered investigational agent within 6 months(180 days).

2. Patient whose prognosis is regarded as less than 12 months.

3. Patient considered to be improper to this study by attending doctor
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Ito
Organization Okayama Univesity Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Cardiovascular Medicine
Zip code
Address 2-5-1, Shikata-cho, Kita-ku, Okayama
TEL 086-235-7349
Email itomd@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kunihisa Kohno
Organization Okayama university hospital
Division name Department of Cardiovascular Medicine
Zip code
Address 2-5-1, Shikata-cho, Kita-ku, Okayama
TEL 086-235-7351
Homepage URL
Email kunihisakohno@msn.com

Sponsor
Institute Department of Cardiovascular Medicine, Okayama Univesity Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization donated commission management fund
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Biopharmaceutics, School of Pharmacy, Kumamoto University
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 岡山大学病院(岡山県)、津山中央病院(岡山県)

Other administrative information
Date of disclosure of the study information
2014 Year 07 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
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 Open public recruiting
Date of protocol fixation
2014 Year 06 Month 24 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 01 Day
Last follow-up date
2016 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We measure a sequence of blood concentration of indoxyl sulfate and P-cresol 3 or 4 times at urgent hospitalization(day1-3), 1 week(day4-12) , 1 months(day13-40), and ,if possible, 1 year(10-14 months) after hospitalization.

Management information
Registered date
2014 Year 06 Month 25 Day
Last modified on
2016 Year 12 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016733

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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