UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052883 |
|---|---|
| Receipt number | R000060344 |
| Scientific Title | Investigation of factors that improve exercise tolerance in patients undergoing transcatheter aortic valve implantation: Quantitative visualization of breathlessness using acoustic data |
| Date of disclosure of the study information | 2023/11/23 |
| Last modified on | 2024/05/24 15:32:10 |
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Basic information
Public title
Investigation of factors that improve exercise tolerance in patients undergoing transcatheter aortic valve implantation: Quantitative visualization of breathlessness using acoustic data
Acronym
Quantitative visualization of breathlessness using acoustic data
Scientific Title
Investigation of factors that improve exercise tolerance in patients undergoing transcatheter aortic valve implantation: Quantitative visualization of breathlessness using acoustic data
Scientific Title:Acronym
Quantitative visualization of breathlessness using acoustic data
Region
| Japan |
Condition
Condition
Patients with cardiovascular diseases
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to clarify the factors that positively influence the improvement of exercise tolerance in patients with aortic valve stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI), we investigated cardiac conditions before and after TAVI. To examine changes in exercise tolerance over time before and after rehabilitation, and the factors that influence its improvement, in comparison with non-AS cardiovascular disease patients. Furthermore, as one of the factors, we will clarify whether it is possible to visualize "shortness of breath" using acoustic data.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Research 1: Factors that influence exercise tolerance and its improvement in patients undergoing TAVI. To examine changes in 6-minute walking distance before and after TAVI and the factors that influence its improvement.
Research 2: Factors influencing the improvement of exercise tolerance by cardiac rehabilitation in patients undergoing TAVI. We will examine the factors that affect the frequency and frequency of cardiac rehabilitation and the changes in 6-minute walking distance 5 months after discharge and its improvement.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) AS patients undergoing TAVI at the Department of Cardiovascular Medicine, Kitasato University Hospital
2) Heart disease patients without AS (Hospitalized for treatment of heart failure, coronary artery disease and arrhythmia)
3) Among the above 1) and 2), patients judged to require cardiac rehabilitation and undergo physical function evaluation.
4) Receive written and verbal explanations about the content of this research, fully understand it, and decide to become a subject of the research.
Patients who can give consent
Key exclusion criteria
1) Measurement of 6-minute walking distance due to orthopedic disease or central nervous system disease that severely interferes with daily life patients who cannot perform
2) Severe heart failure patients with NT-proBNP of 4000 pg/mL or higher
3) Patients receiving dialysis treatment
4) Patients with atrial fibrillation
5) Patients who have a pacemaker or other device inserted into their chest
6) Patients undergoing treatment for malignant tumors
7) Patients with obvious dementia
Target sample size
88
Research contact person
Name of lead principal investigator
| 1st name | Minako |
| Middle name | |
| Last name | Yamaoka-tojo |
Organization
Kitasato University
Division name
School of Allied Health Sciences
Zip code
252-0373
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL
0427788111
myamaoka@med.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Minako |
| Middle name | |
| Last name | Yamaoka-Tojo |
Organization
Kitasato University
Division name
School of Allied Health Sciences
Zip code
252-0373
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL
0427788111
Homepage URL
myamaoka@med.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
NTT
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University School of Medicine and Hospital Observational and Epidemiological Research Review Committee
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Japan
Tel
0427788111
rinrib@med.kitasato-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
| 2023 | Year | 11 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
53
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
| 2022 | Year | 10 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Clinical data such as background information and test data will be collected from the medical records of AS patients undergoing TAVI at Kitasato University Hospital and heart disease patients without AS as a control group. During the 6-minute walk test, which is measured during physical function evaluation in cardiac rehabilitation, biological data will be acquired using an acoustic data measurement device (BMP-LD2) regarding changes in heart rate, heart sounds, and heart murmurs.
Management information
Registered date
| 2023 | Year | 11 | Month | 23 | Day |
Last modified on
| 2024 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060344
