A Study Using Spinal Stimulation During Exercise in Patients with Heart Failure
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 14-002521
NCT ID: NCT02659202
Sponsor Protocol Number: 14-002521
About this study
The purpose of this study is to determine if epidural spinal cord stimulation can affect blood pressure control and blood vessel resistance during exercise in heart failure patients by intercepting messages of muscle fatigue and shortness of breath.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Heart Failure patients with reduced ejection fraction
- History of ischemic or idiopathic dilated cardiomyopathy (duration > 1yr) stable for > 3mo and New York Heart Association Class I-III
- Not pacemaker dependent
- Body Mass Index ≤35
- Ejection Fraction < 40%
- Current nonsmokers with < 15 pack year history
- Able to exercise
Exclusion Criteria
- History of cardiopulmonary disorders and dangerous arrhythmias
- Pregnant women
- Taking prescribed opioid medications or have had a fusion or laminectomy at L3 or above
- Have a recent drug-eluding stent
- History of spinal stenosis, lumbar radiculopathy, or peripheral neuropathy
- Must not currently be taking blood thinners or anticoagulant medications
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Bruce Johnson, Ph.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available