Neuromodulation to improve heart failure symptoms and function

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.