UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015291
Receipt number R000017788
Scientific Title Frequency and characteristics of CD36 deficient patients among heart failure and cardiomyopathy
Date of disclosure of the study information 2014/10/01
Last modified on 2015/10/03 13:23:51

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Basic information

Public title

Frequency and characteristics of CD36 deficient patients among heart failure and cardiomyopathy

Acronym

Heart disease and CD36 deficiency

Scientific Title

Frequency and characteristics of CD36 deficient patients among heart failure and cardiomyopathy

Scientific Title:Acronym

Heart disease and CD36 deficiency

Region

Japan


Condition

Condition

heart failure, cardiomyopathy, CD36 deficiency

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To study frequency and characteristics of CD36 deficient patients among patients diagnosed with heart failure and cardiomyopathy

Basic objectives2

Others

Basic objectives -Others

pathophysiology, prospective observational study

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

To study frequency of type I or type II CD36 deficient patients among patients diagnosed with heart failure and cardiomyopathy

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

20 years-old <=

Age-upper limit

85 years-old >=

Gender

Male and Female

Key inclusion criteria

Hospitalized patients to treat heart failure or for close examination for cardiomyopathy

Key exclusion criteria

Patients with severe liver dysfunction
Patients with severe renal dysfunction

Target sample size

200


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tatsuya Iso

Organization

Gunma University Graduate School of Medicine

Division name

Education and Research Support Center

Zip code


Address

3-39-22 Showa-machi, Maebashi, Gunma

TEL

027-220-8145

Email

isot@gunma-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tatsuya Iso

Organization

Gunma University Graduate School of Medicine

Division name

Education and Research Support Center

Zip code


Address

3-39-22 Showa-machi, Maebashi, Gunma

TEL

027-220-8145

Homepage URL


Email

isot@gunma-u.ac.jp


Sponsor or person

Institute

Gunma University Graduate School of Medicine
Department of Cardiovascular Medicine

Institute

Department

Personal name



Funding Source

Organization

Gunma University Graduate School of Medicine
Department of Medicine and Biological Science

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2014 Year 10 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

Terminated

Date of protocol fixation

2014 Year 09 Month 24 Day

Date of IRB


Anticipated trial start date

2014 Year 10 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We studied CD36 expression in platelet and monocyte in patients hospitalized for cardiac disease. We found type II deficiency in a patient among twenty we examined.


Management information

Registered date

2014 Year 09 Month 30 Day

Last modified on

2015 Year 10 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017788


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name