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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035987
Receipt No. R000040989
Scientific Title Hyperthyroidism and acute decompensated heart failure: A multi-center retrospective cohort study
Date of disclosure of the study information 2019/04/01
Last modified on 2020/08/26

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Basic information
Public title Hyperthyroidism and acute decompensated heart failure: A multi-center retrospective cohort study
Acronym Hyperthyroidism and acute heart failure
Scientific Title Hyperthyroidism and acute decompensated heart failure: A multi-center retrospective cohort study
Scientific Title:Acronym Hyperthyroidism and acute heart failure
Region
Japan

Condition
Condition Acute decompensated heart failure with hyperthyroidism
Classification by specialty
Cardiology Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the prevalence, clinical/laboratory characteristics of hyperthyroidism in heart failure patients.
We will also evaluate the prognosis of those patients to compare with heart failure patients without hyperthyroidism.
Basic objectives2 Others
Basic objectives -Others Cohort study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cardiovascular mortality
Key secondary outcomes All-cause mortality, in-hospital mortality, heart failure readmission, control of atrial fibrillation, length of hospital stay.

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 Hospitalized patients with heart failure and hyperthyroidism from April 1st, 2010 to December 31st, 2017.
Key exclusion criteria 1. Patients in which there was not enough clinical data for analysis.
2. Patients who were judged as unsuitable for the study by the investigator for other reasons.
Target sample size 150

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
Zip code 224-8503
Address 35-1, Chigasaki-Chuo, Tsuzuki, Yokohama, Kanagawa, Japan
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
Zip code 224-8503
Address 35-1, Chigasaki-Chuo, Tsuzuki, Yokohama, Kanagawa, Japan
TEL 045-949-7000
Homepage URL
Email alone_with_music@hotmail.com

Sponsor
Institute Showa University Northern Yokohama Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Showa University Fujigaoka Hospital, St. Marianna University School of Medicine Hospital, St. Marianna University School of Medicine, Yokohama City Seibu Hospital, Yokohama Municipal Citizen's Hospital.
Name of secondary funder(s)

IRB Contact (For public release)
Organization by the Institutional Review Board of Showa University Northern Yokohama Hospital
Address 35-1, Chigasaki-Chuo, Tsuzuki, Yokohama, Kanagawa, Japan
Tel 0459497000
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
2019 Year 04 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
2019 Year 03 Month 01 Day
Date of IRB
2018 Year 09 Month 15 Day
Anticipated trial start date
2019 Year 04 Month 01 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2019 Year 02 Month 24 Day
Last modified on
2020 Year 08 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040989

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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