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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000040250
Receipt No. R000045918
Scientific Title Changes of D-dimer in preventive period for COVID-19 for patients with chronic heart failure
Date of disclosure of the study information 2020/04/30
Last modified on 2021/02/06

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Basic information
Public title Changes of D-dimer in preventive period for COVID-19 for patients with chronic heart failure
Acronym Changes of D-dimer in preventive period for COVID-19 for patients with chronic heart failure
Scientific Title Changes of D-dimer in preventive period for COVID-19 for patients with chronic heart failure
Scientific Title:Acronym Changes of D-dimer in preventive period for COVID-19 for patients with chronic heart failure
Region
Japan

Condition
Condition Chronic heart failure
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To observe the change of D-daimar during preventive period for COVID-19 for patients with chronic heart failure
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes D-dimaer
Key secondary outcomes SF
BNP
HbA1c
Hb, Ht, Plt
Questionnaire about activity

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
100 years-old >
Gender Male and Female
Key inclusion criteria Chronic heart failure
Key exclusion criteria None
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Akira
Middle name
Last name Sezai
Organization Nihon University School of Medicine
Division name Department of Cardiovascular Surgery
Zip code 1738610
Address 30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
TEL 0339728111
Email asezai.med@gmail.com

Public contact
Name of contact person
1st name Akira
Middle name
Last name Sezai
Organization Nihon University School of Medicine
Division name Department of Cardiovascular Surgery
Zip code 1738610
Address 30-1 Oyaguchi kami-machi, Itabashi-ku, Tokyo, Japan
TEL 0339728111
Homepage URL
Email asezai.med@gmail.com

Sponsor
Institute Nihon University School of Medicine
Institute
Department

Funding Source
Organization Self funding
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 None
Address None
Tel None
Email None

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 日本大学板橋病院、関野病院

Other administrative information
Date of disclosure of the study information
2020 Year 04 Month 30 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
2020 Year 04 Month 27 Day
Date of IRB
2020 Year 04 Month 07 Day
Anticipated trial start date
2020 Year 05 Month 08 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective observation trial

Management information
Registered date
2020 Year 04 Month 27 Day
Last modified on
2021 Year 02 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045918

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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