Heart Failure
Conditions
Keywords
Exercise, Heart Failure, Blood Pressure
Brief summary
The purpose of this proposal is to determine whether epidural spinal cord stimulation can modulate cardiovascular control during exercise in Heart Failure patients.
Detailed description
Forty Heart Failure (\>18 yrs. of age) will be recruited. The study will include a total of 2 visits. All experiments will take place at the Mayo Clinic; at the outpatient radiology for MRI screening, the Charlton Clinical Research Unit (CRU) for surgical suite for spinal cord stimulation placement and the Saint Mary's Hospital Clinical Research Unit for clinical exercise laboratory for the exercise protocol and overnight stay. Study visit 1 will include eligibility screening, consenting process, completion of a health questionnaire and performance of a peak oxygen consumption (VO2) test. Additionally, subjects will undergo a screening lumbar MRI to ensure that there are no anatomical anomalies in or around the epidural area consistent with standard clinical practice for epidural stimulator lead placement associated with chronic pain syndromes. Study visit 2 will include an overnight stay in the Saint Mary's Hospital Clinical Research Unit. Patients will check in to the CRU in the morning of day 1, visit 2. Prior to placement of stimulating electrodes an international normalized ratio (INR) will be checked to ensure safe clotting. An anesthesiologist will place the electrodes in the lumbar/thoracic epidural space in a manner that is standard for the clinical placement of temporary electrodes in humans. The participants will then transfer to the clinical exercise laboratory to start the exercise protocol. Participants will rest 15 minutes prior to starting exercise. Exercise will take place on a vertical bike where they will perform a submaximal cycling exercise at 30% of peak work for 29 minutes. Thigh cuffs will be placed on thigh bilaterally and inflated intermittently to pressures of 80m mmHg. After the testing is complete, participants will return to their room in the Clinical Research Unit for the rest of the day and sty over night. On day two of visit two, participants will repeat the testing from day one with new randomization to determine reliability of testing performed on day one. After the exercise on day two of visit two, the spinal cord stimulator leads and radial arterial catheter will be removed.
Interventions
DEVICEPrecision Spinal Cord Stimulator System
The precision system will consist of a pulse generator that will not be implanted, temporary percutaneous leads, surgical paddle leads and lead extensions, each packaged as a separate kit.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
, includes: * 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
includes: * History of cardiopulmonary disorders and dangerous arrhythmias * Pregnant women * Taking prescribed opioid medications or have had a fusion or laminectomy at L3 or above * Patients with a recent drug-eluding stent * History of spinal stenosis, lumbar radiculopathy, or peripheral neuropathy * Must not currently be taking blood thinners or anticoagulant medications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Arterial Pressure | 2 days | This will allow for continuous real-time intra-arterial measurement of beat-to-beat blood pressure. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Precision Spinal Cord Stimulator System Intervention:the precision system will consist of a pulse generator that will not be implanted, temporary percutaneous leads lead extensions, each packaged as a separate kit.
Precision Spinal Cord Stimulator System: The precision system will consist of a pulse generator that will not be implanted, temporary percutaneous leads, surgical paddle leads and lead extensions, each packaged as a separate kit. | 7 |
| Total | 7 |
Baseline characteristics
| Characteristic | Precision Spinal Cord Stimulator System |
|---|---|
| Age, Continuous | 63.0 years STANDARD_DEVIATION 16.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 7 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 7 |
| other Total, other adverse events | 1 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
Mean Arterial Pressure
This will allow for continuous real-time intra-arterial measurement of beat-to-beat blood pressure.
Time frame: 2 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Precision Spinal Cord Stimulator System | Mean Arterial Pressure | 82.3 mmHg | Standard Deviation 10.1 |