UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043258 |
|---|---|
| Receipt number | R000049373 |
| Scientific Title | Prospective observational study to identify the prevalence of osteoporosis in patients with heart failure |
| Date of disclosure of the study information | 2021/02/05 |
| Last modified on | 2021/08/19 13:54:13 |
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Basic information
Public title
Prospective observational study to identify the prevalence of osteoporosis in patients with heart failure
Acronym
The prevalence of osteoporosis in patients with heart failure
Scientific Title
Prospective observational study to identify the prevalence of osteoporosis in patients with heart failure
Scientific Title:Acronym
The prevalence of osteoporosis in patients with heart failure
Region
| Japan |
Condition
Condition
Chronic heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the prevalence and characteristics of osteoporosis in elderly patients with heart failure
Basic objectives2
Others
Basic objectives -Others
Descriptive study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The prevalence and characteristics of osteoporosis in elderly patients with heart failure
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
1.Stage B and C heart failure
2.over 65 years
Key exclusion criteria
None
Target sample size
300
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
Japan Osteoporosis Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
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 | 05 | 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
| 2020 | Year | 08 | Month | 03 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. Gender, age, past history, comorbidities, medication
2. Kihon checklist, NYHA
3. Height, weight, vital signs
4. Blood test
5. 12 Lead ECG
6. Echocardiography
7. FRAX
8. Dual Energy X-ray Absorption
9. Spine radiograph
Management information
Registered date
| 2021 | Year | 02 | Month | 05 | Day |
Last modified on
| 2021 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049373
