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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035827
Receipt No. R000040814
Scientific Title Comparison of clinical significance of novel reactive oxygen species biomarker among new categories of non-ischemic heart failure
Date of disclosure of the study information 2019/02/14
Last modified on 2019/02/09

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Basic information
Public title Comparison of clinical significance of novel reactive oxygen species biomarker among new categories of non-ischemic heart failure
Acronym Reactive oxygen species in non-ischemic heart failure
Scientific Title Comparison of clinical significance of novel reactive oxygen species biomarker among new categories of non-ischemic heart failure
Scientific Title:Acronym Reactive oxygen species in non-ischemic heart failure
Region
Japan

Condition
Condition non-ischemic heart failure
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In non-ischemic heart failure patients, to assess the relationship between reactive oxygen metabolites and other biomarker, and to compare among categories of heart failure, and to investigate the prognostic involvement of reactive oxygen metabolites in the future cardiovascular events.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Composite endpoint of cardiovascular death, non-fatal myocardial infarction, unstable angina pectoris, non-fatal stroke, or re-hospitalization for heart failure
Key secondary outcomes

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients with heart failure who were hospitalized in Kumamoto University Hospital
Key exclusion criteria Do not meet diagnostic criteria for non-ischemic heart failure
Severe valvular disease
Active infection diseases
History of malignancy
End stage of chronic kidney diseases
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenichi Tsujita
Organization Graduate School of Medical Sciences, Kumamoto University
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1-1 Honjo, Chuo-ku, Kumamoto, Japan
TEL 81-96-373-5175
Email cvmhisho@kumamoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Taiki Nishihara
Organization Graduate School of Medical Sciences, Kumamoto University
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1-1 Honjo, Chuo-ku, Kumamoto, Japan
TEL 81-96-373-5175
Homepage URL
Email t-nishi@kumamoto-u.ac.jp

Sponsor
Institute Kumamoto University
Institute
Department

Funding Source
Organization Kumamoto University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 熊本大学病院(熊本県)

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 14 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
2007 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 02 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Patients were followed at the outpatient clinic until January 2019 or until an endpoint occured.

Management information
Registered date
2019 Year 02 Month 09 Day
Last modified on
2019 Year 02 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040814

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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