Noninvasive Neuromodulation to Reserve Diastolic Dysfunction

Heart Failure, Diastolic Clinical Trial

— NERDD  

Official title:

Noninvasive Neuromodulation to Reserve Diastolic Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02983448
• Other study ID #: IRB-7147
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: April 2018

Study information

• Verified date: June 2019
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Diastolic

Intervention

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

Locations

Country	Name	City	State
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Echocardiographic Markers of Diastolic Dysfunction	Global longitudinal strain	after 1 hour of stimulation
Secondary	Heart Rate Variability Measures	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.	after 1 hour of stimulation