UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043427 |
|---|---|
| Receipt number | R000049584 |
| Scientific Title | Nagasaki Heart Failure Registry |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2022/09/12 17:08:11 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Nagasaki Heart Failure Registry
Acronym
Nagasaki Heart Failure Registry
Scientific Title
Nagasaki Heart Failure Registry
Scientific Title:Acronym
Nagasaki Heart Failure Registry
Region
| Japan |
Condition
Condition
Chronic Heart Failure
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, to investigate the relationship between the cause of heart failure, treatment, pneumococcal vaccine intake and hospitalization for exacerbation of heart failure and death from heart failure in chronic heart failure patients attending outpatient clinics, we established a registry of patients attending cardiovascular outpatient clinics in acute hospitals. and prognosis of patients with heart failure in the prefecture, and to examine factors contributing to prognosis.
Basic objectives2
Others
Basic objectives -Others
Pneumonia requiring hospitalisation, pneumococcal pneumonia requiring hospitalisation, invasive pneumococcal infection requiring hospitalisation
pneumonia requiring hospitalisation, pneumococcal pneumonia requiring hospitalisation, invasive pneumococcal infection requiring hospitalisation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hospitalization for worsening heart failure and death from 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
A. Patients aged 65 years or older at the time of consent
B. Diagnosed with heart failure and a history of heart failure hospitalization at the study site within 5 years
C. Currently attending the study site at the time of study entry
Key exclusion criteria
none
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Koji |
| Middle name | |
| Last name | Maemura |
Organization
Nagasaki University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
852-8501
Address
Sakamoto 1-7-1, Nagasaki, Japan
TEL
095-819-7288
maemura@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Yoshimura |
Organization
Nagasaki University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
852-8501
Address
Sakamoto 1-7-1, Nagasaki, Japan
TEL
095-819-7288
Homepage URL
yoshimuras1986@gmail.com
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Nagasaki Univercity
Address
Sakamoto 1-7-1, Nagasaki, Japan
Tel
0958197198
yoshimuras1986@gmail.com
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 | 04 | 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
| 2021 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research Period
The day of approval by the Nagasaki University Ethics Committee - December 31, 2026
Registration Period
The day of approval by the Nagasaki University Ethics Committee - 31 December 2026
The follow-up period
The day of approval by the Nagasaki University Ethical Committee - 31 December 2026
Management information
Registered date
| 2021 | Year | 02 | Month | 24 | 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=R000049584
