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Spinal Stimulation During Exercise in Heart Failure

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ClinicalTrials.gov Identifier: NCT02659202
Recruitment Status : Recruiting
First Posted : January 20, 2016
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Bruce Johnson, Mayo Clinic

Study Description
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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.

Condition or disease Intervention/treatment Phase
Heart Failure Device: Precision Spinal Cord Stimulator System Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Spinal Cord Stimulation to Inhibit Afferent Feedback During Exercise in Heart Failure
Actual Study Start Date : January 2016
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Device: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Mean Arterial Pressure [ Time Frame: 2 days ]
    This will allow for continuous real-time intra-arterial measurement of beat-to-beat blood pressure.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02659202


Contacts
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Contact: Briana Ziegler, BS 507-255-7125 ziegler.briana@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic in Rochester Recruiting
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Bruce Johnson, PhD Mayo Clinic
More Information
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Additional Information:

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Responsible Party: Bruce Johnson, PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02659202    
Other Study ID Numbers: 14-002521
First Posted: January 20, 2016    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Keywords provided by Bruce Johnson, Mayo Clinic:
Exercise
Heart Failure
Blood Pressure
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases