UMIN-CTR Clinical Trial

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