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SPYRAL HTN-ON MED Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02439775
Recruitment Status : Active, not recruiting
First Posted : May 12, 2015
Results First Posted : September 15, 2023
Last Update Posted : April 17, 2024
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

Detailed Description:
The purpose of this study is to test the hypothesis that renal denervation is safe and reduces systolic blood pressure (SBP) in patients with uncontrolled hypertension on one, two, or three standard antihypertensive medications compared to a sham control in the same population. In this study, "uncontrolled hypertension" is defined as an office systolic blood pressure (SBP) ≥ 150 mmHg and <180 mmHg, an office Diastolic Blood Pressure (DBP) ≥90 mmHg and a 24-hour Ambulatory Blood Pressure Monitoring (ABPM) average SBP ≥140 mmHg to <170 mmHg, all of which are measured at Screening Visits. Data obtained will be used to confirm the effect of renal denervation on elevated blood pressure in patients on 1, 2 or 3 antihypertensive medications.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 337 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
Actual Primary Completion Date : August 18, 2022
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine


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) ]
    The primary safety endpoint of the study is the incidence of Major Adverse Events (MAE), defined as a composite of the following events: 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%, confirmed by angiography and as a determined by the angiographic core laboratory, through one-month post-randomization (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 ]
    Baseline adjusted change (using Analysis of Covariance) in systolic blood pressure (SBP) from baseline (Screening Visit 2) to 6 months post-procedure as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).


Secondary Outcome Measures :
  1. Change in Office Systolic Blood Pressure [ Time Frame: From baseline to 6 months post-procedure ]
    Change in office systolic blood pressure from baseline (Screening Visit 2) to 6 months post-procedure

  2. Antihypertensive Medication Usage and Changes to 6-months [ Time Frame: From baseline to 6-month post-procedure ]
    Number of medications from baseline (Screening Visit 2) through 6 Months post-procedure

  3. Antihypertensive Medication Burden to 6-months [ Time Frame: From baseline to 6 Months post-procedure ]

    Based on the prescribed medications reported, medication burden was calculated using Medication Index 2 score which is a composite index based on the doses of antihypertensive medications multiplied by the number of medications prescribed; all classes (ACE/ARB, calcium channel blockers, etc.) were considered equivalent in potency. Higher score indicates higher dosages being prescribed over the standard dose.

    Minimum value 0; No Maximum value


  4. Medication Changes [ Time Frame: Baseline to 6-months post-procedure ]
    Patients who had medication changes based on Medication Index 2 drug testing data. Medication Index 2 score is a composite index based on the doses of antihypertensive medications multiplied by the number of medications prescribed; all classes (ACE/ARB, calcium channel blockers, etc.) were considered equivalent in potency.

  5. Incidence of Achieving Target Office Systolic Blood Pressure [ Time Frame: From baseline to 6 months post-procedure ]
    Incidence of achieving target office systolic blood pressure (SBP<140 mmHg) at 6 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
  Study Documents (Full-Text)

Documents provided by Medtronic Vascular:
Study Protocol  [PDF] September 10, 2020
Statistical Analysis Plan  [PDF] May 17, 2022

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
Results First Posted: September 15, 2023
Last Update Posted: April 17, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Medtronic Vascular:
Uncontrolled hypertension
Renal denervation
Additional relevant MeSH terms:
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Hypertension
Cardiovascular Diseases
Vascular Diseases