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Neuromodulation of Inflammation and Endothelial Function

RecruitingNAAges 18 Years - 85 YearsAllUniversity of Oklahoma
NCT05230732 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 patient's over the age of 50, continuing to experience symptoms, reduced exercise capacity and poor quality of life. We have previously demonstrated that low level transcutaneous electrical stimulation of the vagus nerve at the tragus (LLTS) suppresses inflammation in patients with atrial fibrillation and diastolic dysfunction and improved endothelial dysfunction in patients with chronic heart failure. The overall objective of this proposal is to examine the effects of LLTS on heart failure symptoms, exercise capacity and quality of life in patients with HFrEF and simultaneously determine the impact of LLTS on the suppression of inflammation and improvement in endothelial function. Our specific a

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📋 Eligibility rules (as published)
Inclusion Criteria: Systolic heart failure with EF \< or equal to 50%. Exclusion Criteria: 1. patients in overt congestive heart failure / recent acute myocardial infarction (\< 4 weeks) or Unstable angina 2. Active malignancy 3. unilateral or bilateral vagotomy 4. pregnant patients 5. End stage liver disease 6. history of recurrent vasovagal syncope, Sick sinus syndrome with no pacemaker, 2nd or 3rd degree AV block. 7. Significant hypotension (Blood pressure \< 90 mm Hg) secondary to autonomic dysfunction
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What it tests

  • neuromodulation device
  • SHAM
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Where

1 site
University of Oklahoma Health Sciences Center
Oklahoma City, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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