UMIN-CTR Clinical Trial

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

Severe aortic stenosis

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

Email

yamakatu@hama-med.ac.jp

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

Email

07485098@hama-med.ac.jp

Institute

Hamamatsu University School of Medicine,University Hospital

Institute

Department

Personal name

Organization

No

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Hamamatsu University School of Medicine,University Hospital

Address

1-20-1 Handayama, Higashi-ku, Hamamatsu City, Shizuoka Prefecture

Tel

053-435-211

Email

yamakatu@hama-med.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

浜松医科大学医学部附属病院

Date of disclosure of the study information

2020

Year

06

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

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