UMIN-CTR Clinical Trial

Basic information
Public title	Relation of plasma xanthine oxidation-reduction enzyme activity and various factors in patients with cardiovascular disease and/or heart failure
Acronym	Xanthine oxidation-reduction enzyme activity in patients with cardiovascular disease
Scientific Title	Relation of plasma xanthine oxidation-reduction enzyme activity and various factors in patients with cardiovascular disease and/or heart failure
Scientific Title:Acronym	Xanthine oxidation-reduction enzyme activity in patients with cardiovascular disease
Region	Japan

Condition
Condition	cardiovascular disease heart failure
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the plasma XOR activity in the patients with cardiovascular disease.
Basic objectives2	Others
Basic objectives -Others	To evaluate the plasma XOR activity in the patients with heart failure.
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Measured value of the plasma XOR activity in patients with cardiovascular disease
Key secondary outcomes	Measured value of the plasma XOR activity in patients with heart failure

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	Male or female patients over 20 years old at time the subjects sign the Informed Consent Form (ICF).
Key exclusion criteria	Patients who are judged as inappropriate for inclusion by physicians.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Nobukazu Ishizaka
Organization	Osaka Medical College
Division name	Department of Cardiology
Zip code
Address	2-7 Daigakucho, Takatuski, Osaka
TEL	072-683-1221
Email	ishizaka@osaka-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yumiko Kanzaki
Organization	Osaka Medical College
Division name	Department of Cardiology
Zip code
Address	2-7 Daigakucho, Takatuski, Osaka
TEL	072-683-1221
Homepage URL
Email	in3089@poh.osaka-med.ac.jp

Sponsor
Institute	Department of Cardiology Osaka Medical College
Institute
Department

Funding Source
Organization	SANWA KAGAKU KENKYUSHO CO.,LTD
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	JAPAN

Other related organizations
Co-sponsor	SANWA KAGAKU KENKYUSHO CO.,LTD
Name of secondary funder(s)	not applicable

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

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 11 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	No longer recruiting
Date of protocol fixation	2016 Year 05 Month 02 Day
Date of IRB	2016 Year 05 Month 02 Day
Anticipated trial start date	2016 Year 05 Month 11 Day
Last follow-up date	2019 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2016 Year 05 Month 11 Day
Last modified on	2020 Year 11 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025656