Noninvasive Neuromodulation to Reserve Diastolic Dysfunction

Not Applicable

Completed

• Conditions: Heart Failure, Diastolic
• Interventions: Device: transcutaneous vagus nerve stimulation

• Registration Number: NCT02983448
• Lead Sponsor: University of Oklahoma

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-30
• Study Start: 2016-12
• Study First Submitted QC: 2016-12-01
• Study First Posted: 2016-12-06
• Primary Completion: 2018-03
• Study Completion: 2018-04
• Results First Submitted: 2019-04-19
• Results First Submitted QC: 2019-05-20
• Status Verified: 2019-06
• Results First Posted: 2019-06-11
• Last Update Submitted: 2019-06-13
• Last Update Posted: 2019-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active stimulation first	transcutaneous vagus nerve stimulation	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.
Sham stimulation first	transcutaneous vagus nerve stimulation	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.

Primary Outcome Measures

Name	Time	Method
Echocardiographic Markers of Diastolic Dysfunction	after 1 hour of stimulation	Global longitudinal strain

Secondary Outcome Measures

Name	Time	Method
Heart Rate Variability Measures	after 1 hour of stimulation	low frequency to high frequency ratio. This is a measure of sympathovagal balance. A lower value reflects a more favorable balance between sympathetic and parasympathetic (vagal) tone.

Trial Locations

Locations (1)

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States