UMIN-CTR Clinical Trial

Basic information
Public title	Renal functional improvement after transcatheter aortic valve implantation in patients with chronic kidney disease
Acronym	Renal functional improvement after TAVI in CKD patients
Scientific Title	Renal functional improvement after transcatheter aortic valve implantation in patients with chronic kidney disease
Scientific Title:Acronym	Renal functional improvement after TAVI in CKD patients
Region	Japan

Condition
Condition	severe aortic valve stenosis chronic kidney disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The current study was aimed to clarify preoperative predictors for renal functional improvement after transcatheter aortic valve implantation (TAVI) in patients with severe aortic valve stenosis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We evaluated the change in estimated glomerular filtration rate (eGFR) from the baseline to discharge after TAVI.
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	This single-center cohort study included consecutive severe AS patients with CKD (grade >=3) who underwent TAVI in the single university hospital from December 2015 to May 2019.
Key exclusion criteria	CKD grade <3
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Nobuhisa Middle name Last name Hagiwara
Organization	Tokyo Women's Medical University
Division name	Cardiology
Zip code	1628666
Address	8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL	+8133538111
Email	hagiwara.nobuhisa@twmu.ac.jp

Public contact
Name of contact person	1st name Kentaro Middle name Last name Jujo
Organization	Tokyo Women's Medical University
Division name	Cardiology
Zip code	1628666
Address	8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL	+8133538111
Homepage URL
Email	juken1123@mac.com

Sponsor
Institute	Tokyo Women's Medical University
Institute
Department

Funding Source
Organization	Tokyo Women's Medical 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	Ethical review board of Tokyo Women's Medical University
Address	8-1 Kawada-cho, Shinjuku-ku, Tokyo
Tel	03-3353-8111
Email	krinri.bm@twmu.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	2019 Year 11 Month 16 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	121
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	Completed
Date of protocol fixation	2019 Year 08 Month 06 Day
Date of IRB	2019 Year 11 Month 11 Day
Anticipated trial start date	2019 Year 11 Month 12 Day
Last follow-up date	2020 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Preoperatively, a high mean transaortic pressure gradient and a low peak velocity of the early wave (E) to early diastole (e) ratio (E/e) could predict RF improvement after TAVI in patients with CKD.

Management information
Registered date	2019 Year 11 Month 14 Day
Last modified on	2020 Year 05 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043943