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SPYRAL HTN-ON MED Study

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 : November 7, 2023
Sponsor:
Information provided by (Responsible Party):
Medtronic Vascular

Tracking Information
First Submitted Date  ICMJE April 28, 2015
First Posted Date  ICMJE May 12, 2015
Results First Submitted Date  ICMJE August 18, 2023
Results First Posted Date  ICMJE September 15, 2023
Last Update Posted Date November 7, 2023
Actual Study Start Date  ICMJE July 2015
Actual Primary Completion Date August 18, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 18, 2023)
  • 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).
  • 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).
Original Primary Outcome Measures  ICMJE
 (submitted: May 6, 2015)
  • Acute and chronic safety by evaluating incidence of Major Adverse Events [ Time Frame: From baseline to 36 months post-procedure ]
  • Change in systolic blood pressure as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) [ Time Frame: From baseline to 36 months post-procedure ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2023)
  • 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
  • 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
  • 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
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2015)
  • Change in office systolic blood pressure [ Time Frame: From baseline to 36 months post-procedure ]
  • Incidence of achieving target office systolic blood pressure (SBP<140 mmHg or <130 mmHg for patients with diabetes or renal disease) [ Time Frame: From 1 month to 36 months post-procedure ]
  • Change in office diastolic blood pressure [ Time Frame: From baseline to 36 months post-procedure ]
  • Change in diastolic blood pressure as measured by 24-hour ABPM [ Time Frame: From baseline to 36 months post-procedure ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SPYRAL HTN-ON MED Study
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypertension
  • Vascular Diseases
  • Cardiovascular Diseases
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Renal Denervation
    Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
    Intervention: Device: Symplicity Spyral™ multi-electrode renal denervation system
  • Sham Comparator: Sham Procedure
    Renal angiography
    Intervention: Procedure: Sham Procedure
Publications *

*   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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: April 7, 2022)
337
Original Estimated Enrollment  ICMJE
 (submitted: May 6, 2015)
100
Estimated Study Completion Date  ICMJE October 2025
Actual Primary Completion Date August 18, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Canada,   France,   Germany,   Greece,   Ireland,   Japan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02439775
Other Study ID Numbers  ICMJE SPYRAL HTN-ON MED
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Medtronic Vascular
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Medtronic Vascular
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Medtronic Vascular
Verification Date November 2023

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