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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name