NCT02983448

Brief Summary

This is a 2x2 cross over pilot study using low level transcutaneous vagus nerve stimulation (LLTS) to reverse diastolic dysfunction in patients with diastolic dysfunction. All patients will receive 2 separate, 1-hour sequences, at least 1 day apart, of active and sham LLTS, but the sequence will be randomized. Patients will be randomly assigned (1:1) to active/sham or sham/active LLTS. LLTS will be performed using a transcutaneous electrical nerve stimulation (TENS) device with electrodes attached to the tragus of the ear, which is innervated by auricular branch of the vagus nerve. Echocardiography will be performed after 30 minutes of LLTS or sham stimulation to assess diastolic function. Five-minute ECGs will be obtained for HRV analysis every 15 minutes of stimulation (total of 4 recordings).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 6, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 11, 2019

Completed
Last Updated

June 25, 2019

Status Verified

June 1, 2019

Enrollment Period

1.2 years

First QC Date

November 30, 2016

Results QC Date

April 19, 2019

Last Update Submit

June 13, 2019

Conditions

Heart Failure, Diastolic

Outcome Measures

Primary Outcomes (1)

  • Echocardiographic Markers of Diastolic Dysfunction

    Global longitudinal strain

    after 1 hour of stimulation

Secondary Outcomes (1)

  • Heart Rate Variability Measures

    after 1 hour of stimulation

Study Arms (2)

Sham stimulation first

PLACEBO COMPARATOR

Sham stimulation delivered at the earlobe (devoid of vagal innervation) is given on first session. Transcutaneous vagus nerve stimulation delivered at the tragus (vagal innervation) is given on second session.

Device: transcutaneous vagus nerve stimulation

Active stimulation first

ACTIVE COMPARATOR

Transcutaneous vagus nerve stimulation delivered at the earlobe (vagal innervation) is given on first session. Sham stimulation delivered at the tragus (devoid of vagal innervation) is given on second session.

Device: transcutaneous vagus nerve stimulation

Interventions

transcutaneous vagus nerve stimulationDEVICE

All patients will receive both active and sham transcutaneous vagus nerve stimulation, with the order being randomized

Active stimulation firstSham stimulation first

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients older than 18 year old
  • Evidence of diastolic dysfunction on echocardiogram within 24 months of study enrollment

You may not qualify if:

  • Left ventricular dysfunction (Left ventricular ejection fraction \<40%)
  • Significant valvular disorder (i.e., prosthetic valve or hemodynamically relevant valvular diseases)
  • Recent (\<6 months) stroke or myocardial infarction
  • Severe heart failure (NYHA class III or IV)
  • Recurrent vaso-vagal syncopal episodes
  • Unilateral or bilateral vagotomy
  • Pregnancy or breast feeding
  • Sick sinus syndrome (without a pacemaker), 2nd or 3rd degree AV block, bifascicular block or prolonged (PR\>300ms) 1st degree AV block

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Related Publications (1)

  • Tran N, Asad Z, Elkholey K, Scherlag BJ, Po SS, Stavrakis S. Autonomic Neuromodulation Acutely Ameliorates Left Ventricular Strain in Humans. J Cardiovasc Transl Res. 2019 Jun;12(3):221-230. doi: 10.1007/s12265-018-9853-6. Epub 2018 Dec 17.

    PMID: 30560316DERIVED

MeSH Terms

Conditions

Heart Failure, Diastolic

Condition Hierarchy (Ancestors)

Heart FailureHeart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Dr. Stavros Stavrakis
Organization
University of Oklahoma Health Sciences Center
stavros-stavrakis@ouhsc.edu
405-271-4742

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 30, 2016

First Posted

December 6, 2016

Study Start

December 1, 2016

Primary Completion

March 1, 2018

Study Completion

April 1, 2018

Last Updated

June 25, 2019

Results First Posted

June 11, 2019

Record last verified: 2019-06

Locations

US(1)