UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044121 |
|---|---|
| Receipt number | R000050382 |
| Scientific Title | Effect of Transcutaneous Vagus Nerve Stimulation (tVNS) on left ventricular afterload in patients with heart failure: A randomized double-blind, sham-controlled trial. |
| Date of disclosure of the study information | 2021/06/01 |
| Last modified on | 2023/05/09 11:40:15 |
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Basic information
Public title
Effect of Transcutaneous Vagus Nerve Stimulation (tVNS) on left ventricular afterload in patients with heart failure: A randomized double-blind, sham-controlled trial.
Acronym
Effect of Transcutaneous Vagus Nerve Stimulation (tVNS) on left ventricular afterload in patients with heart failure: A randomized double-blind, sham-controlled trial.
Scientific Title
Effect of Transcutaneous Vagus Nerve Stimulation (tVNS) on left ventricular afterload in patients with heart failure: A randomized double-blind, sham-controlled trial.
Scientific Title:Acronym
Effect of Transcutaneous Vagus Nerve Stimulation (tVNS) on left ventricular afterload in patients with heart failure: A randomized double-blind, sham-controlled trial.
Region
| Japan |
Condition
Condition
Congestive heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of low level transcutaneous vagus nerve stimulation (tVNS) (low-level tragus stimulation; LLTS) on left ventricular afterload in patients with heart failure.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The degree of reduction in central blood pressure (The comparison of central blood pressure measures before and after 5 days tVNS [one hour per one day])
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved 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
Active LLTS was performed using a tVNS device with an ear clip attached to the tragus of the left ear, which is innervated by auricular branch of the vagus nerve.
Interventions/Control_2
In the sham group, stimulation was delivered to the left ear lobe, which is devoid of vagal innervation.
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
| 40 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. The patients aged from 40 to 85 years old who diagnosed as acute heart failure (AHF) according to the guideline of European Society of Cardiology (June 2021 to June 2022).
2. The AHF patients who have systolic blood pressure more than 100mmHg.
3. The AHF patients who provide written informed consent.
Key exclusion criteria
1. The AHF patients who have multiple organ failure
2. The AHF patients who have systolic blood pressure less than 100mmHg.
3. The AHF patients who have severe bradycardia.
4. The AHF patients who have sepsis.
5. The AHF patients who did not provide written informed consent.
Target sample size
22
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
2-1-1, Kabeminami, 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
2-1-1, Kabeminami, 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
Hiroshima City Asa Hospital
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
2-1-1, Kabeminami, 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
| 2021 | 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
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 06 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | 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
| 2021 | Year | 05 | Month | 06 | Day |
Last modified on
| 2023 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050382
