UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023840
Receipt number R000027471
Scientific Title Retrospective analysis of heart failure patients
Date of disclosure of the study information 2016/08/30
Last modified on 2023/03/06 10:59:21

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Basic information

Public title

Retrospective analysis of heart failure patients

Acronym

Retrospective analysis of heart failure patients

Scientific Title

Retrospective analysis of heart failure patients

Scientific Title:Acronym

Retrospective analysis of heart failure patients

Region

Japan


Condition

Condition

heart failure

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Investigation of prognostic factor in heart failure patients

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Major adverse cardiac event (MACE), including cardiovascular death, non-fatal myocardial infarction, stroke, stent thrombosis, unstable angina and admission due to ischemic heart failure

Key secondary outcomes

all death, malignancy, worsening of renal function, onset of diabetes, hypertension and dyslipidemia, implant of cardiovascular device, non--fatal arrhythmia.
Association with lipid profile, multimodalities and biomarkers.


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who undergo heart failure therapy in Fukui University Hospital

Key exclusion criteria

Patients who do not give consent

Target sample size

4000


Research contact person

Name of lead principal investigator

1st name Tetsuji
Middle name
Last name Morishita

Organization

University of Fukui Hospital

Division name

Department of Cardiovascular Medicine

Zip code

910-1193

Address

23-3, shimoaizuki, matsuoka, eiheiji-cho, yoshida-gun, Fukui, Japan

TEL

0776-61-3111

Email

tmori@u-fukui.ac.jp


Public contact

Name of contact person

1st name Tetsuji
Middle name
Last name Morishita

Organization

University of Fukui Hospital

Division name

Department of Cardiovascular Medicine

Zip code

910-1193

Address

23-3, shimoaizuki, matsuoka, eiheiji-cho, yoshida-gun, Fukui, Japan

TEL

0776-61-3111

Homepage URL


Email

tmori@u-fukui.ac.jp


Sponsor or person

Institute

University of Fukui Hospital
Department of Cardiovascular Medicine

Institute

Department

Personal name



Funding Source

Organization

University of Fukui Hospital
Department of Cardiovascular Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Medical Resaerch Support Center, University of Fukui Hospital

Address

23-3, shimoaizuki, matsuoka, eiheiji-cho, yoshida-gun, Fukui, Japan

Tel

0776-61-8529

Email

tmori@u-fukui.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



Other administrative information

Date of disclosure of the study information

2016 Year 08 Month 30 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

2016 Year 08 Month 18 Day

Date of IRB

2016 Year 10 Month 18 Day

Anticipated trial start date

2016 Year 10 Month 18 Day

Last follow-up date

2026 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Retrospective Cohort Study


Management information

Registered date

2016 Year 08 Month 30 Day

Last modified on

2023 Year 03 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027471


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name