UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035827 |
|---|---|
| Receipt number | 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 | 2021/08/12 17:16:41 |
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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 | 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
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
t-nishi@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040814
