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

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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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049584


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name