Noninvasive Neuromodulation to Reserve Diastolic Dysfunction

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-04-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Heart Failure, Diastolic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Sham stimulation first

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.

Group Type PLACEBO_COMPARATOR

transcutaneous vagus nerve stimulation

Intervention Type DEVICE

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

Active stimulation first

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.

Group Type ACTIVE_COMPARATOR

transcutaneous vagus nerve stimulation

Intervention Type DEVICE

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

Interventions

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transcutaneous vagus nerve stimulation

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No