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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name