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SPYRAL HTN-ON MED Study

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ClinicalTrials.gov Identifier: NCT02439775
Recruitment Status : Enrolling by invitation
First Posted : May 12, 2015
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular

Study Description
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Brief Summary:
The purpose of this study is to test the hypothesis that renal denervation decreases blood pressure and is safe when studied in the presence of up to three standard antihypertensive medications.

Condition or disease Intervention/treatment Phase
Hypertension Vascular Diseases Cardiovascular Diseases Device: Symplicity Spyral™ multi-electrode renal denervation system Procedure: Sham Procedure Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 191 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Global Clinical Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension on Standard Medical Therapy (SPYRAL HTN-ON MED)
Actual Study Start Date : July 2015
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : February 2024

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Renal Denervation
Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
 Device: Symplicity Spyral™ multi-electrode renal denervation system
After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
Other Names:
  • Renal angiography
  • Renal Denervation
Sham Comparator: Sham Procedure
Renal angiography
 Procedure: Sham Procedure
After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
Other Name: Renal angiography


Outcome Measures
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Primary Outcome Measures :
  1. Acute and chronic safety by evaluating incidence of Major Adverse Events [ Time Frame: From baseline to 1 month post-procedure (6 months for new renal artery stenosis) ]
  2. Change in systolic blood pressure as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) [ Time Frame: From baseline to 6 months post-procedure ]

Secondary Outcome Measures :
  1. Change in systolic blood pressure as measured by 24-hour ABPM [ Time Frame: From baseline to 36 months post-procedure ]
  2. Change in diastolic blood pressure as measured by 24-hour ABPM [ Time Frame: From baseline to 36 months post-procedure ]
  3. Change in office systolic blood pressure [ Time Frame: From baseline to 36 months post-procedure ]
  4. Change in office diastolic blood pressure [ Time Frame: From baseline to 36 months post-procedure ]
  5. Incidence of achieving target office systolic blood pressure [ Time Frame: From baseline to 36 months post-procedure ]
  6. Significant embolic event resulting in end-organ damage [ Time Frame: From baseline to 36 months post-procedure ]
  7. Renal artery perforation requiring intervention [ Time Frame: From baseline to 36 months post-procedure ]
  8. Renal artery dissection requiring intervention [ Time Frame: From baseline to 36 months post-procedure ]
  9. Vascular complications [ Time Frame: From baseline to 36 months post-procedure ]
  10. End-stage renal disease [ Time Frame: From baseline to 36 months post-procedure ]
  11. ≥40% decline in eGFR [ Time Frame: From baseline to 36 months post-procedure ]
  12. New myocardial infarction [ Time Frame: From baseline to 36 months post-procedure ]
  13. New stroke [ Time Frame: From baseline to 36 months post-procedure ]
  14. Renal artery re-intervention [ Time Frame: From baseline to 36 months post-procedure ]
  15. Major bleeding according to TIMI definition [ Time Frame: From baseline to 36 months post-procedure ]
  16. Increase in serum creatinine > 50% [ Time Frame: From baseline to 36 months post-procedure ]
  17. New renal artery stenosis > 70% [ Time Frame: From baseline to 36 months post-procedure ]
  18. Hospitalization for hypertensive crisis not related to confirmed nonadherence with medications or the protocol [ Time Frame: From baseline to 36 months post-procedure ]
  19. All-cause mortality [ Time Frame: From baseline to 36 months post-procedure ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individual has office systolic blood pressure (SBP) ≥ 150 mmHg and <180 mmHg and a diastolic blood pressure (DBP) ≥ 90 mmHg when receiving a medication regimen of one, two, or three antihypertensive medication classes.
  • Individual has 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP ≥ 140 mmHg and < 170 mmHg.

Exclusion Criteria:

  • Individual lacks appropriate renal artery anatomy.
  • Individual has estimated glomerular filtration rate (eGFR) of <45.
  • Individual has type 1 diabetes mellitus or poorly-controlled type 2 diabetes mellitus.
  • Individual has one or more episodes of orthostatic hypotension.
  • Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
  • Individual has primary pulmonary hypertension.
  • Individual is pregnant, nursing or planning to become pregnant.
  • Individual has frequent intermittent or chronic pain that results in treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) for two or more days per week over the month prior to enrollment
  • Individual has stable or unstable angina within 3 months of enrollment, myocardial infarction within 3 months of enrollment; heart failure, cerebrovascular accident or transient ischemic attack, or atrial fibrillation at any time.
  • Individual works night shifts.
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): NCT02439775


Locations
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Sponsors and Collaborators
Medtronic Vascular
Investigators
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Principal Investigator: Raymond Townsend, MD University of Pennsylvania
Principal Investigator: David Kandzari, MD Piedmont Hospital
Principal Investigator: Michael Böhm, MD Universitätskliniken des Saarlandes
Principal Investigator: Kazuomi Kario, MD Jichi Medical University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT02439775    
Other Study ID Numbers: SPYRAL HTN-ON MED
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Medtronic Vascular:
Uncontrolled hypertension
Renal denervation
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases