UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief title)	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	Hiroshi Ito
Organization	Okayama Univesity Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Cardiovascular Medicine
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	Kunihisa Kohno
Organization	Okayama university hospital
Division name	Department of Cardiovascular Medicine
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2014 Year 06 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000016733