UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018845 |
|---|---|
| Receipt number | R000021798 |
| Scientific Title | A study to assess the association of serum zinc with severity of heart failure and prognosis. |
| Date of disclosure of the study information | 2015/09/01 |
| Last modified on | 2024/03/05 20:13:10 |
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Basic information
Public title
A study to assess the association of serum zinc with severity of heart failure and prognosis.
Acronym
Zinc in patients with heart failure
Scientific Title
A study to assess the association of serum zinc with severity of heart failure and prognosis.
Scientific Title:Acronym
Zinc in patients with heart failure
Region
| Japan |
Condition
Condition
Acute decompensated heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the association serum zinc and severity of heart failure, and short~mid term prognosis.
Basic objectives2
Others
Basic objectives -Others
Prospective cohort study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In-hospital death, all cause death, cardiovascular death, readmission due to heart failure.
Key secondary outcomes
Laboratory data including BNP, creatinine, eGFR, liver function
Echocardiography, NHYA class
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
Acute decompensated heart failure
Male or female subjects over 20 years of age at the time of informed consent
Ability to provide written informed consent
Key exclusion criteria
Patients with liver cirrhosis, dialysis, inflammatory bowel disease, pancreatitis, systemic inflammatory disease, acute coronary syndrome, or sickle cell disease.
Patients had a history of pancreatectomy or small intestinal resection.
Patients who are judged to be inappropriate to this study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Toshitaka |
| Middle name | |
| Last name | OKABE |
Organization
Showa University Northern Yokohama Hospital
Division name
Division of Cardiology and Cardiac Catheterization Labs
Zip code
224-8503
Address
35-1 Chigasakichuo Tsuzuki-ku Yokohama Kanagawa
TEL
045-949-7000
alone_with_music@hotmail.com
Public contact
Name of contact person
| 1st name | Toshitaka |
| Middle name | |
| Last name | OKABE |
Organization
Showa University Northern Yokohama Hospital
Division name
Division of cardiology and Cardiac Cathteriation Labs
Zip code
224-8503
Address
35-1 Chigasakichuo Tsuzuki-ku Yokohama Kanagawa
TEL
045-949-7000
Homepage URL
alone_with_music@hotmail.com
Sponsor or person
Institute
Showa University Northern Yokohama Hosptal
Institute
Department
Personal name
Funding Source
Organization
None
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
Institutional Review Board of ShowaUniversity Northern Yokohama Hospital
Address
35-1, Chigasaki-Chuo, Tsuzuki, Yokohama, kanagawa, Japan
Tel
0459497977
irb02syh@ofc.showa-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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 01 | 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
Suspended
Date of protocol fixation
| 2015 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A prospective study
Management information
Registered date
| 2015 | Year | 08 | Month | 28 | Day |
Last modified on
| 2024 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021798
