UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000018845
Receipt No. 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 2019/08/31

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email alone_with_music@hotmail.com

Sponsor
Institute Showa University Northern Yokohama Hosptal
Institute
Department

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
Email 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 Open public recruiting
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
2022 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
2019 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021798

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.