UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041799 |
|---|---|
| Receipt number | R000047718 |
| Scientific Title | Prospective Registry of Vaccination for pneumococcal infection and heart failure among the elderly chronic heart failure patients in Nagasaki (PREVENTION-HF in Nagasaki): A prospective cohort study |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2022/09/12 17:09:15 |
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Basic information
Public title
Prospective Registry of Vaccination for pneumococcal infection and heart failure among the elderly chronic heart failure patients in Nagasaki (PREVENTION-HF in Nagasaki): A prospective cohort study
Acronym
PREVENTION-HF in Nagasaki
Scientific Title
Prospective Registry of Vaccination for pneumococcal infection and heart failure among the elderly chronic heart failure patients in Nagasaki (PREVENTION-HF in Nagasaki): A prospective cohort study
Scientific Title:Acronym
PREVENTION-HF in Nagasaki
Region
| Japan |
Condition
Condition
Chronic Heart Failure
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association of pneumococcal vaccination and exacerbation of heart failure (HF) among elderly chronic HF patients.
Basic objectives2
Others
Basic objectives -Others
Significance: Although pneumococcal vaccination for patients with heart failure has been recommended in various guidelines, the actual efficacy of pneumococcal vaccination has not been fully evaluated, and the pneumococcal vaccination rate is low. The present study is the first prospective cohort study to examine the relationship between pneumococcal vaccination and exacerbation of heart failure in the elderly, and if the relationship between pneumococcal vaccination and prevention of exacerbation of heart failure can be demonstrated through this study, it may help to promote pneumococcal vaccination and prevent exacerbation of heart failure in the elderly.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Death from HF in follow up and Hospitalization due to exacerbated HF in follow up
Key secondary outcomes
1. bacterial pneumonia and hospitalization
2. pneumococcal pneumonia and hospitalization
3. Invasive pneumococcal pneumonia and hospitalization
4. all-cause hospitalization
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
Inclusion criteria
A. Age 65 and older at inclusion
B. Patients who were hospitalized each hospital due to HF in previous 5years
C. Those who attend an outpatient clinic of the institutions at the time of the inclusion HF is defined as the HF confirmed by two cardiologists on Framingham HF criteria
Key exclusion criteria
Allergy for vaccine B. Patients with a ventricular assist device C. Patients who have been admitted to a hospital for treatment of HF
Target sample size
1434
Research contact person
Name of lead principal investigator
| 1st name | Taku |
| Middle name | |
| Last name | Iwami |
Organization
Kyoto University, Graduate School of Medicine
Division name
Department of Preventive Services
Zip code
606-8501
Address
Yoshida-honmachi, Sakyo-ku ,Kyoto
TEL
817532424
iwami.taku.8w@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Yoshimura |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Preventive Services
Zip code
606-8501
Address
Yoshida-honmachi, Sakyo-ku ,Kyoto
TEL
817532424
Homepage URL
syoshimura-ngs@umin.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine, Department of preventive services
Institute
Department
Personal name
Funding Source
Organization
Nagasaki Medical Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School of Medicine
Address
Department of Preventive Services
Tel
81757532431
syoshimura-ngs@umin.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
佐世保中央病院(長崎県)、長崎労災病院(長崎県)、佐世保総合医療センター(長崎県)、川棚医療センター(佐賀県)、長崎医療センター(長崎県)、大村市民病院(長崎県)、長崎みなとメディカルセンター(長崎県)、長崎記念病院(長崎県)
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 08 | Month | 19 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
<Name of the organization providing the information>:
1) Sasebo Chuo Hospital
2) Nagasaki Rosai Hospital
3) Sasebo City General Medical Center
4) Nagasaki Kawatana Medical Center
5) Nagasaki Medical Center
6) Omura Municipal Hospital
7) Nagasaki Minato Medical Center
8) Nagasaki Kinen Hospital
<Item of information to be provided>
Medical information within the scope of normal medical practice will be collected from the medical records and routine interviews. This is an observational study and no new interventions or tests will be performed.
Management information
Registered date
| 2020 | Year | 09 | Month | 15 | Day |
Last modified on
| 2022 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047718
