Noninvasive Neuromodulation to Reserve Diastolic Dysfunction
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 5/30/2018 |
| Start Date: | December 2016 |
| End Date: | April 2018 |
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).
(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).
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
We found this trial at
1
site
940 NE 13th St
Oklahoma City, Oklahoma 73190
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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