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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033173
Receipt No. R000037832
Scientific Title Impact of frailty on postoperative cardiac rehabilitation in patients with severe aortic stenosis
Date of disclosure of the study information 2018/07/01
Last modified on 2020/04/15

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Basic information
Public title Impact of frailty on postoperative cardiac rehabilitation in patients with severe aortic stenosis
Acronym Impact of frailty on postoperative condition in aortic stenosis patients
Scientific Title Impact of frailty on postoperative cardiac rehabilitation in patients with severe aortic stenosis
Scientific Title:Acronym Impact of frailty on postoperative condition in aortic stenosis patients
Region
Japan

Condition
Condition aortic stenosis
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Impact of frailty on postoperative condition in patients with severe aortic stenosis
Basic objectives2 Others
Basic objectives -Others none
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes postoperative complications, postoperative 6-minute walking distance (6MWD), and home discharge rates.
Key secondary outcomes ICU stay, Ambulation independent day, Post operative hospital stay


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
100 years-old >
Gender Male and Female
Key inclusion criteria 1.Patients with sever aortic stenosis who underwent Surgical Aortic Valve Replacement or Transcatheter Aortic ValveImplantation in Kobe university hospital
2.patients provided informed consent
Key exclusion criteria 1.Hospital death
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Seimi
Middle name
Last name Kobayashi
Organization Kobe University Graduate School of Medicine
Division name Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code 650-0017
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe
TEL 0783825846
Email seimik@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name Seimi
Middle name
Last name Kobayashi
Organization Kobe University Graduate School of Medicine
Division name Division of Cardiovascular Medicine, Department of Internal Medicine
Zip code 650-0017
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe
TEL 0783825846
Homepage URL
Email seimik@med.kobe-u.ac.jp

Sponsor
Institute Kobe university
Institute
Department

Funding Source
Organization Kobe university
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 Kobe university CTRC
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe
Tel 078-382-6669
Email chiken@med.kobe-u.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
2018 Year 07 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 No longer recruiting
Date of protocol fixation
2018 Year 08 Month 31 Day
Date of IRB
2020 Year 03 Month 31 Day
Anticipated trial start date
2013 Year 12 Month 01 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A single center observational study.
We will investigate the imapct of frailty on post operative condition in patients with sever aortic patients underwent surgical aortic valve replacement or transcatheter aortic valve replacement

Management information
Registered date
2018 Year 06 Month 28 Day
Last modified on
2020 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037832

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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