UMIN-CTR Clinical Trial

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
Email	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
Email	yoshimuras1986@gmail.com

Sponsor
Institute	Nagasaki University Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049584