Neuromodulation for Systolic Heart Failure
This study is looking at whether a neuromodulation device can help people with systolic heart failure (when your heart muscle can't pump blood as well as it should). Researchers want to see if stimulating a nerve in the ear, called the vagus nerve, can improve how far you can walk in 6 minutes. You might receive either the active neuromodulation device, which attaches to the tragus of your ear, or a sham device, which attaches to your earlobe. Both devices are used for 1 hour daily for 12 weeks. This study is open to people aged 18 to 85 with systolic heart failure whose heart's pumping ability (ejection fraction) is 50% or less. The study aims to enroll 158 participants.
- Study design
- This is a randomized, double-blind study comparing active neuromodulation to a sham treatment. It plans to include 158 participants.
- What's involved
- Participants will use a neuromodulation device for 1 hour daily for 12 weeks. You will have a 6-minute walk test and complete a heart failure questionnaire at the beginning and after 3 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be assessed at 3 months after starting treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Neuromodulation of Inflammation and Endothelial Function
At a glance
Conditions
NCT05230732
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahomastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Tarun Dasari, MD, MPH · PRINCIPAL_INVESTIGATOR · University of Oklahoma
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- 6MWDChange in 6MWD after 12 weeks compared to baseline
6 minute walk distance