Status:
RECRUITING
Neuromodulation of Inflammation and Endothelial Function
Lead Sponsor:
University of Oklahoma
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Systolic Heart Failure
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Heart failure with reduced ejection fraction (HFrEF) is a major cause of mortality in United States. Aging is a major risk factor for adverse outcomes associated with HFrEF, with majority of the patie...
Detailed Description
Prospective randomized double-blind study of Lowlevel Tragus stimulation-LLTS vs. sham treatment. We will require n=108 participants (54 in each group) to reach statistical significance and to accoun...
Eligibility Criteria
Inclusion
- Systolic heart failure with EF \< or equal to 50%.
Exclusion
- patients in overt congestive heart failure / recent acute myocardial infarction (\< 4 weeks) or Unstable angina
- Active malignancy
- unilateral or bilateral vagotomy
- pregnant patients
- End stage liver disease
- history of recurrent vasovagal syncope, Sick sinus syndrome with no pacemaker, 2nd or 3rd degree AV block.
- Significant hypotension (Blood pressure \< 90 mm Hg) secondary to autonomic dysfunction
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 27 2026
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT05230732
Start Date
September 1 2022
End Date
February 27 2026
Last Update
April 15 2025
Active Locations (1)
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1
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73117