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Neuromodulation of Inflammation and Endothelial Function

Neuromodulation of Inflammation and Endothelial Function to Treat Elderly Patients With Systolic Heart Failure

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 3 months
  • Procedures mentioned: Questionnaires, Pills, Heart tracing (ECG)

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "To examine the medium term effect of intermittent (1 hour daily for 3 months) LLTS on exercise capacity and quality of life, related to sham stimulation, in patients with HFrEF, 2."
  • "Objective 2: assess the effects of medium-term LLTS on quality of life in subjects with HF - quality of life will be determined using standard HF questionnaire (MLWHF score)."
  • "This questionnaire will be administered at baseline and after 3 months."
  • "Study will be administered by our research coordinator either on paper or tablet."
  • "Aim2: Objective 1: measure the effects of medium-term LLTS on sympathovagal balance in subjects with HF - Heart rate variability (HRV), a well-established, noninvasive measure of autonomic function, will be measured and analyzed via 10 min ECG using standard Labscribe and Kubios software."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests gentle electrical stimulation of a nerve at the outer ear in people with heart failure whose heart pumps less blood than normal. It compares stimulation for 1 hour daily for 3 months with sham (inactive) stimulation. Researchers will study heart failure symptoms, ability to exercise, quality of life, inflammation, and how well blood vessels work.

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 aims include: 1. To examine the medium term effect of intermittent (1 hour daily for 3 months) LLTS on exercise capacity and quality of life, related to sham stimulation, in patients with HFrEF, 2. To determine the effects of medium-term LLTS on sympathovagal/autonomic balance (assessed by heart rate variability) and systemic inflammation in patients with HFrEF and 3. To determine the effects of medium-term LLTS on endothelial function in patients with HFrEF. The proposed proof-of-concept human studies will provide the basis for the design of further human studies using LLTS among larger populations with HFrEF. In light of the increasing number of elderly patients who continue to experience HFrEF symptoms, recognized is a key point of interest in this funding mechanism, and the suboptimal success of the currently available treatment options to ameliorate the problems mentioned above, an alternative novel approach such as LLTS has the potential to impact clinical practice and improve health outcomes among the large number of patients. It is anticipated that these investigations will contribute to a broader understanding of the role of autonomic imbalance, inflammation and endothelial dysfunction in the pathogenesis of HFrEF and how its inhibition can be used to provide therapeutic effects. Moreover, it is anticipated that a better understanding of how modulation of autonomic tone, inflammation and endothelial function affects one of the hallmarks of HFrEF will lead to the development of normal nonpharmacological and pharmacological approaches to treat this disease.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Heart failure with an ejection fraction of 50% or less. This means the heart pumps out no more than half of the blood in its main pumping chamber with each beat.

Who can't join

  • Clear signs of congestive heart failure (fluid buildup), a heart attack within the past 4 weeks, or unstable angina (new or worsening chest pain).
  • Active cancer.
  • Surgery that cut the vagus nerve on one or both sides of the body.
  • Pregnant.
  • End-stage liver disease.
  • Repeated fainting from sudden drops in heart rate or blood pressure; sick sinus syndrome (a heart rhythm problem) without a pacemaker; or second- or third-degree heart block (blocked electrical signals in the heart).
  • Blood pressure below 90 mm Hg due to problems with the nerves that control automatic body functions.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

OK