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Completed

NCT Number: NCT02983448

Noninvasive Neuromodulation to Reserve Diastolic Dysfunction

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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Key information

Conditions

Heart Failure, Diastolic Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 <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

Treatment and study plan

Transcutaneous vagus nerve stimulation

Device

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

Primary outcomes

  1. Echocardiographic Markers of Diastolic Dysfunction

    Time frame: after 1 hour of stimulation

    Global longitudinal strain

Secondary outcomes

  1. Heart Rate Variability Measures

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Acronym: NERDD

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 6, 2016
Registry last updated
Jun 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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