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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038912
Receipt No. R000044366
Scientific Title Relationship between long-term prognosis and frailty in patients with cardiovascular disease
Date of disclosure of the study information 2019/12/17
Last modified on 2020/04/06

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Basic information
Public title Relationship between long-term prognosis and frailty in patients with cardiovascular disease
Acronym Relationship between long-term prognosis and frailty in patients with cardiovascular disease
Scientific Title Relationship between long-term prognosis and frailty in patients with cardiovascular disease
Scientific Title:Acronym Relationship between long-term prognosis and frailty in patients with cardiovascular disease
Region
Japan

Condition
Condition Patients with cardiovascular disease including congestive heart failure and acute myocardial infarction
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate prognostic impact of frailty in patients with cardiovascular disease
Basic objectives2 Others
Basic objectives -Others Evaluation of frailty
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes All-cause mortality
Key secondary outcomes In-hospital mortality
Heart Failure rehospitalization
Acute kidney injury/worsening renal function
Urine output during hospitalization
Skeletal muscle mass
Brain-derived neurotrophic factor (BDNF)
Gait speed
Grip strength
Maximal oxygen consumption

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
90 years-old >=
Gender Male and Female
Key inclusion criteria Patients hospitalizaed with acute heart failure or acute myocardial infarction
Key exclusion criteria 1)Patients with out-of-hospital cardiac arrest
2)Patients with malignant disease with life expectancy within 1 year
3)Patinets with no obtained informed concent
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Koichiro
Middle name
Last name Matsumura
Organization Kansai Medical University Medical Center
Division name Department of Cardiology
Zip code 5708507
Address 10-15, Fumizono-cho, Moriguchi, Osaka
TEL 0669921001
Email kmatsumura1980@yahoo.co.jp

Public contact
Name of contact person
1st name Shinobu
Middle name
Last name Bandou
Organization Kansai Medical University Medical Center
Division name Department of Cardiology
Zip code 5708507
Address 10-15, Fumizono-cho, Moriguchi, Osaka
TEL 0669921001
Homepage URL
Email bandoshi@takii.kmu.ac.jp

Sponsor
Institute Kansai Medical University
Institute
Department

Funding Source
Organization Kansai Medical University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Kansai Medical University
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kansai Medical University Medical Center
Address 10-15, Fumizono-cho, Moriguchi, Osaka
Tel 0669921001
Email bandoshi@takii.kmu.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 関西医科大学総合医療センター(大阪)、関西医科大学附属病院(大阪)

Other administrative information
Date of disclosure of the study information
2019 Year 12 Month 17 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 Open public recruiting
Date of protocol fixation
2019 Year 10 Month 08 Day
Date of IRB
2019 Year 10 Month 08 Day
Anticipated trial start date
2019 Year 10 Month 08 Day
Last follow-up date
2029 Year 10 Month 07 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Evaluation of treatment detail during hospitalization and subsequent long-term outcome

Management information
Registered date
2019 Year 12 Month 17 Day
Last modified on
2020 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044366

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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