UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043297 |
|---|---|
| Receipt number | R000049411 |
| Scientific Title | Cancer morbidity in patients with cardiac dysfunction with left ventricular ejection fraction <50% |
| Date of disclosure of the study information | 2021/02/10 |
| Last modified on | 2022/08/13 17:34:34 |
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Basic information
Public title
Cancer morbidity in patients with cardiac dysfunction with left ventricular ejection fraction <50%
Acronym
Cancer morbidity in patients with cardiac dysfunction
Scientific Title
Cancer morbidity in patients with cardiac dysfunction with left ventricular ejection fraction <50%
Scientific Title:Acronym
Cancer morbidity in patients with cardiac dysfunction
Region
| Japan |
Condition
Condition
heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To identify the cancer morbidity of patients with cardiac dysfunction
Basic objectives2
Others
Basic objectives -Others
Descriptive study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cancer morbidity of patients with cardiac dysfunction
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with echocardiographic evidence of left ventricular ejection fraction of 50% or less
Key exclusion criteria
None
Target sample size
3000
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Fujiki |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Department of Cardiovascular Biology and Medicine
Zip code
951-8510
Address
1-757 Asahimachidori, Chuo-ku, Niigata
TEL
025-227-2185
sfujiki@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Fujiki |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Department of Cardiovascular Biology and Medicine
Zip code
951-8510
Address
1-757 Asahimachidori, Chuo-ku, Niigata
TEL
025-227-2185
Homepage URL
sfujiki@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
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
The ethical committees of Niigata University
Address
1-757 Asahimachidori, Chuo-ku, Niigata
Tel
025-227-2625
ethics@adm.niigata-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
| 2021 | Year | 02 | Month | 10 | 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 | 06 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Gender, age, past history, comorbidities, medication
2. Date of onset, type of cancer
3. Height, weight, vital signs
4. Blood test
5. 12 Lead ECG
6. Echocardiography
Management information
Registered date
| 2021 | Year | 02 | Month | 10 | Day |
Last modified on
| 2022 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049411
| 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 |
