UMIN-CTR Clinical Trial

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
Email	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
Email	syoshimura-ngs@umin.ac.jp

Sponsor
Institute	Kyoto University Graduate School of Medicine, Department of preventive services
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047718