Neuromodulation to improve heart failure symptoms and function
Neuromodulation of Inflammation and Endothelial Function to Treat Elderly Patients With Systolic Heart Failure
NA · University of Oklahoma · NCT05230732
This study is testing whether a gentle electrical stimulation of the vagus nerve can help people with heart failure feel better and improve their ability to exercise over three months.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 158 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University of Oklahoma (other) |
| Locations | 1 site (Oklahoma City, Oklahoma) |
| Trial ID | NCT05230732 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of low-level transcutaneous electrical stimulation of the vagus nerve on patients with heart failure with reduced ejection fraction (HFrEF). It aims to assess improvements in exercise capacity, quality of life, and inflammation suppression over a three-month period. Participants will be randomly assigned to receive either the active treatment or a sham treatment, with various assessments conducted to measure outcomes. The study will enroll a total of 158 patients, including a control group for comparison.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 and older with systolic heart failure and an ejection fraction of 50% or less.
Not a fit: Patients with recent acute myocardial infarction, active malignancy, or significant hypotension may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the quality of life and exercise capacity for patients suffering from heart failure.
How similar studies have performed: Previous studies have shown promising results with similar neuromodulation techniques in related conditions, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Oklahoma City, Oklahoma
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States (RECRUITING)
Study contacts
- Principal investigator: Tarun Dasari, MD, MPH — University of Oklahoma
- Study coordinator: Tarun Dasari, MD,MPH
- Email: tdasari@ouhsc.edu
- Phone: 4052714742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Systolic Heart Failure