UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038576 |
|---|---|
| Receipt number | R000043943 |
| Scientific Title | Renal functional improvement after transcatheter aortic valve implantation in patients with chronic kidney disease |
| Date of disclosure of the study information | 2019/11/16 |
| Last modified on | 2020/05/19 16:49:48 |
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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
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
juken1123@mac.com
Sponsor or person
Institute
Tokyo Women's Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043943
