UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040391 |
|---|---|
| Receipt number | R000045899 |
| Scientific Title | Changes in baroreflex before and after Transcatheter Aortic Valve Implantation. Does autonomic function affect baroreflex recovery? |
| Date of disclosure of the study information | 2020/06/01 |
| Last modified on | 2023/04/24 16:47:11 |
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Basic information
Public title
Changes in baroreflex before and after Transcatheter Aortic Valve Implantation.
Does autonomic function affect baroreflex recovery?
Acronym
Changes in baroreflex before and after Transcatheter Aortic Valve Implantation.
Does autonomic function affect baroreflex recovery?
Scientific Title
Changes in baroreflex before and after Transcatheter Aortic Valve Implantation.
Does autonomic function affect baroreflex recovery?
Scientific Title:Acronym
Changes in baroreflex before and after Transcatheter Aortic Valve Implantation.
Does autonomic function affect baroreflex recovery?
Region
| Japan |
Condition
Condition
Severe aortic stenosis
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether baroreflex changes before and after TAVI are affected by preoperative autonomic function.
Basic objectives2
Others
Basic objectives -Others
A multivariate analysis will be performed on the background factors that were found to be related, in order to search for factors that influence changes in postoperative BRS.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Baroreflex sensitivity
(pre operation,post operation,after 1 year)
Key secondary outcomes
All deaths
Cardiovascular death
All readmissions
Cardiovascular readmission
Heart rate variability analysis
Frailty scale
Barthel Index
Grip strength, knee extension strength, 4m walking speed
Mini-Cog
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Evaluation of autonomic function by heart rate variability analysis
Baroreceptor reflex sensitivity measurement by tilt table test
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with aortic stenosis and undergoing transcatheter aortic valve implantation at our hospital
over 65 years old
Men and women do not matter
Mini Cog 3 points or more
Key exclusion criteria
Patients with a pacemaker inserted
Patients with atrial fibrillation
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yamauti |
| Middle name | |
| Last name | Katsuya |
Organization
Hamamatsu University School of Medicine,University Hospital
Division name
Department of Rehabilitation
Zip code
431-3125
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu City, Shizuoka Prefecture
TEL
053-435-2111
yamakatu@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Toda |
Organization
Hamamatsu University School of Medicine,University Hospital
Division name
Department of Rehabilitation
Zip code
431-3125
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu City, Shizuoka Prefecture
TEL
053-435-2111
Homepage URL
07485098@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine,University Hospital
Institute
Department
Personal name
Funding Source
Organization
No
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu University School of Medicine,University Hospital
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu City, Shizuoka Prefecture
Tel
053-435-211
yamakatu@hama-med.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
浜松医科大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In March 2021, a device failure was discovered. Equipment failures make it difficult to use the data collected so far for statistical analysis. I applied to the Institutional Review Board for the use of the new equipment. Registration for the study was resumed in November with the approval of the Institutional Review Board.
lthough data were collected continuously, there were more subjects with atrial fibrillation than expected among the study subjects.
Since it was difficult to analyze those with atrial fibrillation in the HRV analysis, we determined that it would be difficult to continue the current study and decided to discontinue it.
Management information
Registered date
| 2020 | Year | 05 | Month | 13 | Day |
Last modified on
| 2023 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045899
