UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051017 |
|---|---|
| Receipt number | R000058160 |
| Scientific Title | A role of transcutaneous vagus nerve stimulation on left ventricular function and afterload in Takotsubo syndrome |
| Date of disclosure of the study information | 2023/06/01 |
| Last modified on | 2023/05/09 12:54:11 |
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Basic information
Public title
A role of transcutaneous vagus nerve stimulation on left ventricular function and afterload in Takotsubo syndrome
Acronym
A role of transcutaneous vagus nerve stimulation on left ventricular function and afterload in Takotsubo syndrome
Scientific Title
A role of transcutaneous vagus nerve stimulation on left ventricular function and afterload in Takotsubo syndrome
Scientific Title:Acronym
Vagus nerve stimulation and left ventricle in Takotsubo syndrome
Region
| Japan |
Condition
Condition
Takotsubo syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Low-level tragus stimulation (LLTS) of transcutaneous vagus nerve stimulation (tVNS) is expected to stabilize the sympatho-vagal balance, and is hypothesized to improve left ventricular function and reduce afterload in patients with Takotsubo syndrome. We investigate the acute effects of LLTS compared with sham stimulation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in left ventricular global strain and afterload before and after tVNS
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
In the active LLTS precedent group, a device clip is attached to the left tragus, and stimulation was performed for 1 hour as vagus nerve auricular stimulation. In the Sham stimulation precedent group, a clip was attached to the left earlobe, and stimulation was performed for 1 hour.
Interventions/Control_2
After the Intervention 1, with resting for 1 hour, Sham stimulation is performed in the Active LLTS precedent group, and Active LLTS is performed in the Sham stimulation precedence group, and crossover is performed.
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
| Not applicable |
Gender
Female
Key inclusion criteria
1. The patients diagnosed as Takotsubo syndrome in Hiroshima City Asa Hospital
2. The Takotsubo syndrome patients who have systolic blood pressure more than 100mmHg.
3. The Takotsubo syndrome patients who provide written informed consent.
Key exclusion criteria
1. The Takotsubo syndrome patients who have multiple organ failure.
2. The Takotsubo syndrome patients who have systolic blood pressure less than 100mmHg.
3. The Takotsubo syndrome patients who have severe bradycardia.
4. The Takotsubo syndrome patients who have sepsis.
5. The Takotsubo syndrome patients who did not provide written informed consent.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Michiaki |
| Middle name | |
| Last name | Nagai |
Organization
Hiroshima City Asa Hospital
Division name
Department of Cardiology
Zip code
731-0293
Address
1-2-1, Kameyamaminami, Aaskita-ku, Hiroshima
TEL
082-815-5211
nagai10m@r6.dion.ne.jp
Public contact
Name of contact person
| 1st name | Michiaki |
| Middle name | |
| Last name | Nagai |
Organization
Hiroshima City Asa Hospital
Division name
Department of Cardiology
Zip code
731-0293
Address
1-2-1, Kameyamaminami, Aaskita-ku, Hiroshima
TEL
082-815-5211
Homepage URL
nagai10m@r6.dion.ne.jp
Sponsor or person
Institute
Hiroshima City Asa Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Hiroshima City Asa Hospital
Address
1-2-1, Kameyamaminami, Aaskita-ku, Hiroshima
Tel
082-815-5211
nagai10m@r6.dion.ne.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 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 09 | Day |
Last modified on
| 2023 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058160
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| Registered date | File name |
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