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SPYRAL PIVOTAL - SPYRAL HTN-OFF MED Study

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ClinicalTrials.gov Identifier: NCT02439749
Recruitment Status : Active, not recruiting
First Posted : May 12, 2015
Results First Posted : May 27, 2021
Last Update Posted : May 27, 2021
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular

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 absence of 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 366 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 in the Absence of Antihypertensive Medications (SPYRAL PIVOTAL - SPYRAL HTN-OFF MED)
Actual Study Start Date : June 2015
Actual Primary Completion Date : April 30, 2020
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Incidence of Major Adverse Events (MAE) Defined as a Composite of Events. [ Time Frame: From baseline to 1 month post-procedure ]
    All-cause mortality End-stage Renal Disease (ESRD) Significant embolic event resulting in end-organ damage Renal artery perforation requiring intervention Renal artery dissection requiring intervention Vascular complications Hospitalization for hypertensive crisis not related to confirmed non-adherence with medications or the protocol New renal artery stenosis >70% (6 months for new renal artery stenosis, however endpoint data is reported to 3 months only)

  2. Baseline Adjusted Change (Using Analysis of Covariance) in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring [ Time Frame: From baseline to 3 months post-procedure ]
    The outcome measure is the change in ambulatory systolic blood pressure from baseline to 3-month. The unadjusted treatment difference between renal denervation and sham control groups is -3.9 mmHg. The baseline adjusted treatment difference is -3.9 mmHg.


Secondary Outcome Measures :
  1. Baseline Adjusted Change (Using Analysis of Covariance) in Office Systolic Blood Pressure [ Time Frame: From baseline to 3 months post-procedure ]
    The outcome measure is the change in office systolic blood pressure from baseline to 3-month. The unadjusted treatment difference between renal denervation and sham control groups is -7.0 mmHg. The baseline adjusted treatment difference is -6.9 mmHg.

  2. Significant Embolic Event Resulting in End-organ Damage [ Time Frame: From baseline to 1 month post-procedure ]
    Significant embolic event resulting in end-organ damage (e.g. kidney/bowel infarct, lower extremity ulceration or gangrene, or doubling of serum creatinine documented by at least two measurements at least 21 days apart)

  3. Renal Artery Perforation Requiring Intervention [ Time Frame: From baseline to 1 month post-procedure ]
    Renal artery perforation requiring intervention

  4. Renal Artery Dissection [ Time Frame: From baseline to 1 month post-procedure ]
    Renal artery dissection requiring intervention

  5. Vascular Complications [ Time Frame: From baseline to 1 month post-procedure ]
    Vascular complications (e.g., clinically significant groin hematoma, arteriovenous fistula, pseudoaneurysm, excessive bleeding) requiring surgical repair, interventional procedure, thrombin injection, or blood transfusion (requiring more than 2 units of packed red blood cells within any 24 hour period during the first 7 days post renal denervation procedure).

  6. End-stage Renal Disease [ Time Frame: From baseline to 1 month post-procedure ]

    defined as two or more eGFR measurements < 15 mL/min/1.73m2 at least 21 days apart and requiring dialysis for one of more of the following:

    • Volume management refractory to diuretics
    • Hyperkalemia unmanageable by diet and diuretics
    • Acidosis bicarbonate <18 unmanageable with HCO3 supplements
    • Symptoms of uremia, nausea, vomiting

  7. Decline in eGFR [ Time Frame: From baseline to 1 month post-procedure ]
    ≥40% decline in eGFR

  8. Myocardial Infarction [ Time Frame: From baseline to 1 month post-procedure ]
    New myocardial infarction

  9. New Stroke [ Time Frame: From baseline to 1 month post-procedure ]
    New stroke

  10. Renal Artery Re-intervention [ Time Frame: From baseline to 1 month post-procedure ]
    Renal artery re-intervention

  11. Major Bleeding According to TIMI Definition [ Time Frame: From baseline to 1 month post-procedure ]
    Major bleeding according to TIMI definition (i.e. intracranial hemorrhage, ≥5g/dl decrease in hemoglobin concentration, a ≥15% absolute decrease in hematocrit, or death due to bleeding within 7 days of the procedure).

  12. Increase in Serum Creatinine [ Time Frame: From baseline to 1 month post-procedure ]
    Increase in serum creatinine > 50% from screening visit 2.

  13. New Renal Artery Stenosis > 70% [ Time Frame: From baseline to 6 month post-procedure ]
    Confirmed by angiography and as determined by the angiographic core laboratory.

  14. Hospitalization for Hypertensive Crisis With Medications or the Protocol [ Time Frame: From baseline to 1 month post-procedure ]
    Hospitalization for hypertensive crisis not related to confirmed non-adherence with medications or the protocol.

  15. All-cause Mortality [ Time Frame: From baseline to 3 months post-procedure ]
    All-cause mortality

  16. Change in Systolic Blood Pressure as Measured by 24-hour ABPM [ Time Frame: From baseline to 36 month post-procedure ]
  17. Incidence of Achieving Target Office Systolic Blood Pressure (SBP <140 mmHg) [ Time Frame: From 1 month to 36 months post-procedure ]
  18. Change in Office Diastolic Blood Pressure [ Time Frame: From baseline to 36 months post-procedure ]
    Change in office diastolic blood pressure

  19. Change in Diastolic Blood Pressure as Measured by 24-hour ABPM [ Time Frame: From baseline to 36 months post-procedure ]
    Change in diastolic blood pressure as measured by 24-hour ABPM

  20. End-Stage Renal Disease (ESRD) [ Time Frame: From baseline to 3 months post randomization ]

    Defined as two or more eGFR measurements < 15 mL/min/1.73m2 at least 21 days apart and requiring dialysis for one of more of the following:

    • Volume management refractory to diuretics
    • Hyperkalemia unmanageable by diet and diuretics
    • Acidosis bicarbonate <18 unmanageable with HCO3 supplements
    • Symptoms of uremia, nausea, vomiting

  21. ≥40% Decline in eGFR [ Time Frame: From baseline to 3 months post randomization ]
    ≥40% Decline in eGFR

  22. New Myocardial Infarction [ Time Frame: From baseline to 3 months post randomization ]
    New Myocardial Infarction

  23. New Stroke [ Time Frame: From baseline to 3 months post randomization ]
    New Stroke

  24. Renal Artery Re-intervention [ Time Frame: From baseline to 3 months post randomization ]
    Renal Artery Re-intervention

  25. Major Bleeding According to TIMI Definition [ Time Frame: From baseline to 3 months post randomization ]
    Major bleeding according to TIMI definition (i.e. intracranial hemorrhage, ≥5g/dl decrease in hemoglobin concentration, a ≥15% absolute decrease in hematocrit, or death due to bleeding within 7 days of the procedure).

  26. Increase in Serum Creatinine [ Time Frame: From baseline to 3 months post randomization ]
    Increase in Serum Creatinine > 50% from screening visit 2.

  27. Hospitalization for Hypertensive Crisis [ Time Frame: From baseline to 3 months post randomization ]
    Hospitalization for Hypertensive Crisis Not Related to Confirmed Nonadherence With Medications or the Protocol

  28. Change in Office Systolic Blood Pressure [ Time Frame: From baseline to 1 month post procedure ]
    Change in office systolic blood pressure from baseline (Screening Visit 2) to 1-month

  29. Incidence of Achieving Target Office Systolic Blood Pressure [ Time Frame: From baseline to 1 month post procedure ]
    Incidence of achieving target office systolic blood pressure (SBP <140 mmHg)

  30. Incidence of Achieving Target Office Systolic Blood Pressure [ Time Frame: From baseline to 3 months post procedure ]
    Incidence of Achieving Target Office Systolic Blood Pressure (SBP <140 mmHg)

  31. Change in Office Diastolic Blood Pressure [ Time Frame: From baseline to 1 month post procedure ]
    Change in office diastolic blood pressure from baseline (Screening Visit 2)

  32. Change in Office Diastolic Blood Pressure [ Time Frame: From baseline to 3 months post procedure ]
    Change in Office Diastolic Blood Pressure From Baseline (Screening Visit 2) to 3-months

  33. Change in Diastolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) [ Time Frame: From baseline to 3 months post procedure ]
    Change in diastolic blood pressure from baseline (screening visit 2) to 3-month as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).



Information from the National Library of Medicine

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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 after being off medications.
  • Individual has 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP ≥ 140 mmHg and < 170 mmHg.
  • Individual is willing to discontinue current antihypertensive medications.

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.

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): NCT02439749


Locations
Show Show 47 study locations
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
  Study Documents (Full-Text)

Documents provided by Medtronic Vascular:
Study Protocol  [PDF] October 22, 2020
Statistical Analysis Plan  [PDF] January 6, 2021

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT02439749    
Other Study ID Numbers: SPYRAL HTN-OFF MED
First Posted: May 12, 2015    Key Record Dates
Results First Posted: May 27, 2021
Last Update Posted: May 27, 2021
Last Verified: April 2021

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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
Cardiovascular Diseases
Vascular Diseases