UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Association between reactive oxygen metabolites and severity of heart failure and future cardiovascular events in heart failure with reduced ejection fraction
Title of the study (Brief title)	Heart failure with reduced ejection fraction and reactive oxygen merabolites
Region	Japan

Condition
Condition	Heart failure with reduced ejection fraction
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the relationship between reactive oxygen metabolites and severity of heart failure in patient with heart failure with reduced ejection fraction and to investigate the prognostic involvement of reactive oxygen metabolites in the future cardiovascular events in patients with heart failure with reduced ejection fraction.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Composite endopoint of cardiovascular death, non-fatal myocardial infarction, unstable angina pectoris, non-fatal ischemic stroke, re-hospitalization for heart failure, or coronary revascularization
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 heart failure with preserved ejection fraction Acute coronary syndrome Active infection diseases History of malignancy End stage of chronic kidney diseases
Target sample size	200

Research contact person
Name of lead principal investigator	Hisao Ogawa
Organization	Graduate School of Medical Sciences, Kumamoto University
Division name	Department of Cardiovascular Medicine
Address	1-1-1 Honjo, Kumamoto City, JAPAN
TEL	81-96-373-5175
Email	cvmhisho@kumamoto-u.ac.jp

Public contact
Name of contact person	Takanori Tokitsu
Organization	Graduate School of Medical Sciences, Kumamoto University
Division name	Department of Cardiovascular Medicine
Address	1-1-1 Honjo, Kumamoto City, JAPAN
TEL	81-96-373-5175
Homepage URL
Email	tokitsutakanori@gmail.com

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)

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	2015 Year 01 Month 28 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2008 Year 02 Month 01 Day
Anticipated trial start date	2008 Year 02 Month 10 Day
Last follow-up date
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	Patients are now followed every month at the outpatient clinic.

Management information
Registered date	2015 Year 01 Month 28 Day
Last modified on	2016 Year 10 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019009