N/A
Completed N=24
Noninvasive Neuromodulation to Reserve Diastolic Dysfunction
Heart Failure, Diastolic
Source: ClinicalTrials.gov NCT02983448 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcomePrimary: Echocardiographic Markers of Diastolic Dysfunction — -21.2; -23.0 percent
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Echocardiographic Markers of Diastolic Dysfunction |
-21.2; -23.0 | — |
| SECONDARY Heart Rate Variability Measures |
3.1; 1.8 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female patients older than 18 year old
- Evidence of diastolic dysfunction on echocardiogram within 24 months of study enrollment
Exclusion Criteria
- Left ventricular dysfunction (Left ventricular ejection fraction 300ms) 1st degree AV block
Data sourced from ClinicalTrials.gov (NCT02983448). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.