UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035987 |
|---|---|
| Receipt number | 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 | 2023/08/29 11:31:39 |
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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
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
alone_with_music@hotmail.com
Sponsor or person
Institute
Showa University Northern Yokohama Hospital
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
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
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
N/A
Publication of results
Unpublished
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
40
Results
N/A
Results date posted
| 2023 | Year | 02 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
N/A
Participant flow
N/A
Adverse events
N/A
Outcome measures
N/A
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Suspended
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
| 2024 | 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
| 2023 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040989
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
