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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 9, 2021
Sponsor:
Information provided by (Responsible Party):
Bruce Johnson, Mayo Clinic

Tracking Information
First Submitted Date  ICMJE January 11, 2016
First Posted Date  ICMJE January 20, 2016
Last Update Posted Date February 9, 2021
Actual Study Start Date  ICMJE January 2016
Estimated Primary Completion Date December 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2016)
Mean Arterial Pressure [ Time Frame: 2 days ]
This will allow for continuous real-time intra-arterial measurement of beat-to-beat blood pressure.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Spinal Stimulation During Exercise in Heart Failure
Official Title  ICMJE Spinal Cord Stimulation to Inhibit Afferent Feedback During Exercise in Heart Failure
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Heart Failure
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Device: Precision Spinal Cord Stimulator System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 14, 2016)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2022
Estimated Primary Completion Date December 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Briana Ziegler, BS 507-255-7125 ziegler.briana@mayo.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02659202
Other Study ID Numbers  ICMJE 14-002521
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bruce Johnson, Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bruce Johnson, PhD Mayo Clinic
PRS Account Mayo Clinic
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP