UMIN-CTR Clinical Trial

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 Kenichi Middle name Last name Tsujita
Organization	Graduate School of Medical Sciences, Kumamoto University
Division name	Department of Cardiovascular Medicine
Zip code	860-8556
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 Taiki Middle name Last name Nishihara
Organization	Graduate School of Medical Sciences, Kumamoto University
Division name	Department of Cardiovascular Medicine
Zip code	860-8556
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	Graduate School of Medical Science, Kumamoto University
Address	1-1-1 Honjo, Chuo-ku, Kumamoto, Japan
Tel	81-96-373-5175
Email	ski-shien@jimu.kumamoto-u.ac.jp

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	https://www.ahajournals.org/doi/full/10.1161/JAHA.120.016765?af=R
Publication of results	Published

Result
URL related to results and publications	https://www.ahajournals.org/doi/full/10.1161/JAHA.120.016765?af=R
Number of participants that the trial has enrolled	201
Results	DROM measurements can provide important prognostic information for risk stratification in any category of NIHF.
Results date posted	2021 Year 08 Month 12 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	We recruited 201 consecutively hospitalized patients with HF and measured DROM under stable conditions.
Participant flow	We divided them according to new categories of HF (HF with reduced ejection fraction [EF], HF with midrangeEF, and HF with preserved EF) without coronary artery disease.
Adverse events	N/A
Outcome measures	We investigated the clinical significance of derivatives of reactive oxygen metabolites (DROMs), a new marker of reactive oxygen species, in patients with nonischemic heart failure (HF) and compared them among new categories of HF.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2007 Year 02 Month 01 Day
Date of IRB	2017 Year 09 Month 19 Day
Anticipated trial start date	2007 Year 02 Month 10 Day
Last follow-up date	2020 Year 03 Month 31 Day
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	2021 Year 08 Month 12 Day

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