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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02439749
Registration number
NCT02439749
Ethics application status
Date submitted
28/04/2015
Date registered
12/05/2015
Date last updated
18/04/2024
Titles & IDs
Public title
SPYRAL PIVOTAL - SPYRAL HTN-OFF MED Study
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Scientific 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)
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Secondary ID [1]
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SPYRAL HTN-OFF MED
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hypertension
0
0
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Vascular Diseases
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0
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Cardiovascular Diseases
0
0
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Condition category
Condition code
Cardiovascular
0
0
0
0
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Hypertension
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Cardiovascular
0
0
0
0
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Symplicity Spyral™ multi-electrode renal denervation system
Treatment: Surgery - Sham Procedure
Experimental: Renal Denervation - Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
Sham comparator: Sham Procedure - Renal angiography
Treatment: Devices: 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.
Treatment: Surgery: 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.
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Intervention code [1]
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Treatment: Devices
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Intervention code [2]
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Treatment: Surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Major Adverse Events (MAE) Defined as a Composite of Events.
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Assessment method [1]
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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)
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Timepoint [1]
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From baseline to 1 month post-procedure
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Primary outcome [2]
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Baseline Adjusted Change (Using Analysis of Covariance) in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring
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Assessment method [2]
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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.
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Timepoint [2]
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From baseline to 3 months post-procedure
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Secondary outcome [1]
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Baseline Adjusted Change (Using Analysis of Covariance) in Office Systolic Blood Pressure
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Assessment method [1]
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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.
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Timepoint [1]
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From baseline to 3 months post-procedure
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Secondary outcome [2]
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Number of Participants With Significant Embolic Event Resulting in End-organ Damage
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Assessment method [2]
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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)
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Timepoint [2]
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From baseline to 1 month post-procedure
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Secondary outcome [3]
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Number of Participants With Renal Artery Perforation Requiring Intervention
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Assessment method [3]
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Renal artery perforation requiring intervention
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Timepoint [3]
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From baseline to 1 month post-procedure
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Secondary outcome [4]
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Renal Artery Dissection
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Assessment method [4]
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Number of Participants with Renal artery dissection requiring intervention
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Timepoint [4]
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From baseline to 1 month post-procedure
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Secondary outcome [5]
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Number of Participants With Vascular Complications
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Assessment method [5]
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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).
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Timepoint [5]
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0
From baseline to 1 month post-procedure
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Secondary outcome [6]
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Number of Participants With End-stage Renal Disease
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Assessment method [6]
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0
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
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Timepoint [6]
0
0
From baseline to 1 month post-procedure
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Secondary outcome [7]
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Number of Participants With Decline in eGFR
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Assessment method [7]
0
0
=40% decline in eGFR
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Timepoint [7]
0
0
From baseline to 1 month post-procedure
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Secondary outcome [8]
0
0
Myocardial Infarction
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Assessment method [8]
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Number of Participants with New myocardial infarction
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Timepoint [8]
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From baseline to 1 month post-procedure
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Secondary outcome [9]
0
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New Stroke
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Assessment method [9]
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Number of Participants with New stroke
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Timepoint [9]
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From baseline to 1 month post-procedure
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Secondary outcome [10]
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Number of Participants With Renal Artery Re-intervention
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Assessment method [10]
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Renal artery re-intervention
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Timepoint [10]
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From baseline to 1 month post-procedure
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Secondary outcome [11]
0
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Number of Participants With Major Bleeding According to TIMI Definition
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Assessment method [11]
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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).
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Timepoint [11]
0
0
From baseline to 1 month post-procedure
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Secondary outcome [12]
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Number of Participants With Increase in Serum Creatinine
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Assessment method [12]
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Increase in serum creatinine \> 50% from screening visit 2.
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Timepoint [12]
0
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From baseline to 1 month post-procedure
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Secondary outcome [13]
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Number of Participants With New Renal Artery Stenosis > 70%
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Assessment method [13]
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Confirmed by angiography and as determined by the angiographic core laboratory.
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Timepoint [13]
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From baseline to 6 month post-procedure
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Secondary outcome [14]
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Number of Participants With Hospitalization for Hypertensive Crisis With Medications or the Protocol
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Assessment method [14]
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Hospitalization for hypertensive crisis not related to confirmed non-adherence with medications or the protocol.
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Timepoint [14]
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From baseline to 1 month post-procedure
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Secondary outcome [15]
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Number of Participants With All-cause Mortality
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Assessment method [15]
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All-cause mortality
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Timepoint [15]
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From baseline to 3 months post-procedure
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Secondary outcome [16]
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Number of Participants With Change in Systolic Blood Pressure as Measured by 24-hour ABPM
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Assessment method [16]
0
0
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Timepoint [16]
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From baseline to 36 month post-procedure
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Secondary outcome [17]
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Number of Participants With Incidence of Achieving Target Office Systolic Blood Pressure (SBP <140 mmHg)
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Assessment method [17]
0
0
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Timepoint [17]
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From 1 month to 36 months post-procedure
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Secondary outcome [18]
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Number of Participants With Change in Office Diastolic Blood Pressure
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Assessment method [18]
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Change in office diastolic blood pressure
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Timepoint [18]
0
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From baseline to 36 months post-procedure
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Secondary outcome [19]
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Number of Participants With Change in Diastolic Blood Pressure as Measured by 24-hour ABPM
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Assessment method [19]
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Change in diastolic blood pressure as measured by 24-hour ABPM
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Timepoint [19]
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From baseline to 36 months post-procedure
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Secondary outcome [20]
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Number of Participants With End-Stage Renal Disease (ESRD)
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Assessment method [20]
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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
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Timepoint [20]
0
0
From baseline to 3 months post randomization
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Secondary outcome [21]
0
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Number of Participants With =40% Decline in eGFR
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Assessment method [21]
0
0
=40% Decline in eGFR
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Timepoint [21]
0
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From baseline to 3 months post randomization
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Secondary outcome [22]
0
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Number of Participants With New Myocardial Infarction
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Assessment method [22]
0
0
New Myocardial Infarction
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Timepoint [22]
0
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From baseline to 3 months post randomization
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Secondary outcome [23]
0
0
New Stroke
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Assessment method [23]
0
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Number of Participants with New Stroke
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Timepoint [23]
0
0
From baseline to 3 months post randomization
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Secondary outcome [24]
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Number of Participants With Renal Artery Re-intervention
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Assessment method [24]
0
0
Renal Artery Re-intervention
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Timepoint [24]
0
0
From baseline to 3 months post randomization
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Secondary outcome [25]
0
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Number of Participants With Major Bleeding According to TIMI Definition
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Assessment method [25]
0
0
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).
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Timepoint [25]
0
0
From baseline to 3 months post randomization
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Secondary outcome [26]
0
0
Increase in Serum Creatinine
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Assessment method [26]
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Number of Participants with Increase in Serum Creatinine \> 50% from screening visit 2.
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Timepoint [26]
0
0
From baseline to 3 months post randomization
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Secondary outcome [27]
0
0
Number of Participants With Hospitalization for Hypertensive Crisis
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Assessment method [27]
0
0
Hospitalization for Hypertensive Crisis Not Related to Confirmed Nonadherence With Medications or the Protocol
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Timepoint [27]
0
0
From baseline to 3 months post randomization
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Secondary outcome [28]
0
0
Change in Office Systolic Blood Pressure
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Assessment method [28]
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0
Change in office systolic blood pressure from baseline (Screening Visit 2) to 1-month
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Timepoint [28]
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0
From baseline to 1 month post procedure
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Secondary outcome [29]
0
0
Number of Participants Achieving Target Office Systolic Blood Pressure
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Assessment method [29]
0
0
Incidence of achieving target office systolic blood pressure (SBP \<140 mmHg)
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Timepoint [29]
0
0
From baseline to 1 month post procedure
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Secondary outcome [30]
0
0
Number of Participants Achieving Target Office Systolic Blood Pressure
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Assessment method [30]
0
0
Incidence of Achieving Target Office Systolic Blood Pressure (SBP \<140 mmHg)
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Timepoint [30]
0
0
From baseline to 3 months post procedure
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Secondary outcome [31]
0
0
Change in Office Diastolic Blood Pressure
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Assessment method [31]
0
0
Change in office diastolic blood pressure from baseline (Screening Visit 2)
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Timepoint [31]
0
0
From baseline to 1 month post procedure
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Secondary outcome [32]
0
0
Change in Office Diastolic Blood Pressure
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Assessment method [32]
0
0
Change in Office Diastolic Blood Pressure From Baseline (Screening Visit 2) to 3-months
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Timepoint [32]
0
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From baseline to 3 months post procedure
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Secondary outcome [33]
0
0
Change in Diastolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)
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Assessment method [33]
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Change in diastolic blood pressure from baseline (screening visit 2) to 3-month as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).
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Timepoint [33]
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From baseline to 3 months post procedure
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Eligibility
Key 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.
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Minimum age
20
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
25/10/2023
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Sample size
Target
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Accrual to date
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Final
366
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Alfred Hospital - Melbourne
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Recruitment postcode(s) [1]
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0
3004 - Melbourne
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Alabama
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Arizona
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Country [3]
0
0
United States of America
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State/province [3]
0
0
California
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Connecticut
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Florida
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Georgia
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Iowa
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Kentucky
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Michigan
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Minnesota
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Mississippi
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Missouri
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Country [13]
0
0
United States of America
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State/province [13]
0
0
New Jersey
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Country [14]
0
0
United States of America
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State/province [14]
0
0
New York
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Country [15]
0
0
United States of America
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State/province [15]
0
0
North Carolina
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Country [16]
0
0
United States of America
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State/province [16]
0
0
Ohio
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Country [17]
0
0
United States of America
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State/province [17]
0
0
Pennsylvania
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Country [18]
0
0
United States of America
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State/province [18]
0
0
Rhode Island
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Country [19]
0
0
United States of America
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State/province [19]
0
0
South Carolina
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Country [20]
0
0
United States of America
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State/province [20]
0
0
Tennessee
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Country [21]
0
0
United States of America
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State/province [21]
0
0
Texas
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Country [22]
0
0
United States of America
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State/province [22]
0
0
West Virginia
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Country [23]
0
0
United States of America
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State/province [23]
0
0
Wisconsin
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Country [24]
0
0
Austria
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State/province [24]
0
0
Wels
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Country [25]
0
0
Canada
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State/province [25]
0
0
Ontario
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Country [26]
0
0
Canada
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State/province [26]
0
0
Quebec
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Country [27]
0
0
Germany
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State/province [27]
0
0
Bad Krozingen
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Country [28]
0
0
Germany
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State/province [28]
0
0
Erlangen
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Country [29]
0
0
Germany
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State/province [29]
0
0
Homburg
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Country [30]
0
0
Germany
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State/province [30]
0
0
Leipzig
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Country [31]
0
0
Germany
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State/province [31]
0
0
Lübeck
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Country [32]
0
0
Greece
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State/province [32]
0
0
Athens
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Country [33]
0
0
Greece
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State/province [33]
0
0
Thessaloniki
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Country [34]
0
0
Ireland
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State/province [34]
0
0
Galway
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Country [35]
0
0
Japan
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State/province [35]
0
0
Tochigi
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Country [36]
0
0
Japan
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State/province [36]
0
0
Tokyo
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Country [37]
0
0
United Kingdom
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State/province [37]
0
0
Cardiff
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Country [38]
0
0
United Kingdom
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State/province [38]
0
0
Exeter
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Country [39]
0
0
United Kingdom
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State/province [39]
0
0
London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Medtronic Vascular
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT02439749
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Trial related presentations / publications
Weber MA, Schmieder RE, Kandzari DE, Townsend RR, Mahfoud F, Tsioufis K, Kario K, Pocock S, Tatakis F, Ewen S, Choi JW, East C, Lee DP, Ma A, Cohen DL, Wilensky R, Devireddy CM, Lea JP, Schmid A, Fahy M, Bohm M. Hypertension urgencies in the SPYRAL HTN-OFF MED Pivotal trial. Clin Res Cardiol. 2022 Nov;111(11):1269-1275. doi: 10.1007/s00392-022-02064-5. Epub 2022 Jul 19. Bohm M, Tsioufis K, Kandzari DE, Kario K, Weber MA, Schmieder RE, Townsend RR, Kulenthiran S, Ukena C, Pocock S, Ewen S, Weil J, Fahy M, Mahfoud F. Effect of Heart Rate on the Outcome of Renal Denervation in Patients With Uncontrolled Hypertension. J Am Coll Cardiol. 2021 Sep 7;78(10):1028-1038. doi: 10.1016/j.jacc.2021.06.044. Mahfoud F, Townsend RR, Kandzari DE, Kario K, Schmieder RE, Tsioufis K, Pocock S, David S, Patel K, Rao A, Walton A, Bloom JE, Weber T, Suppan M, Lauder L, Cohen SA, McKenna P, Fahy M, Bohm M, Weber MA. Changes in Plasma Renin Activity After Renal Artery Sympathetic Denervation. J Am Coll Cardiol. 2021 Jun 15;77(23):2909-2919. doi: 10.1016/j.jacc.2021.04.044. Epub 2021 May 3. Bohm M, Kario K, Kandzari DE, Mahfoud F, Weber MA, Schmieder RE, Tsioufis K, Pocock S, Konstantinidis D, Choi JW, East C, Lee DP, Ma A, Ewen S, Cohen DL, Wilensky R, Devireddy CM, Lea J, Schmid A, Weil J, Agdirlioglu T, Reedus D, Jefferson BK, Reyes D, D'Souza R, Sharp ASP, Sharif F, Fahy M, DeBruin V, Cohen SA, Brar S, Townsend RR; SPYRAL HTN-OFF MED Pivotal Investigators. Efficacy of catheter-based renal denervation in the absence of antihypertensive medications (SPYRAL HTN-OFF MED Pivotal): a multicentre, randomised, sham-controlled trial. Lancet. 2020 May 2;395(10234):1444-1451. doi: 10.1016/S0140-6736(20)30554-7. Epub 2020 Mar 29. Bohm M, Townsend RR, Kario K, Kandzari D, Mahfoud F, Weber MA, Schmieder RE, Tsioufis K, Hickey GL, Fahy M, DeBruin V, Brar S, Pocock S. Rationale and design of two randomized sham-controlled trials of catheter-based renal denervation in subjects with uncontrolled hypertension in the absence (SPYRAL HTN-OFF MED Pivotal) and presence (SPYRAL HTN-ON MED Expansion) of antihypertensive medications: a novel approach using Bayesian design. Clin Res Cardiol. 2020 Mar;109(3):289-302. doi: 10.1007/s00392-020-01595-z. Epub 2020 Feb 7. Erratum In: Clin Res Cardiol. 2020 May;109(5):653. doi: 10.1007/s00392-020-01620-1. Townsend RR, Mahfoud F, Kandzari DE, Kario K, Pocock S, Weber MA, Ewen S, Tsioufis K, Tousoulis D, Sharp ASP, Watkinson AF, Schmieder RE, Schmid A, Choi JW, East C, Walton A, Hopper I, Cohen DL, Wilensky R, Lee DP, Ma A, Devireddy CM, Lea JP, Lurz PC, Fengler K, Davies J, Chapman N, Cohen SA, DeBruin V, Fahy M, Jones DE, Rothman M, Bohm M; SPYRAL HTN-OFF MED trial investigators*. Catheter-based renal denervation in patients with uncontrolled hypertension in the absence of antihypertensive medications (SPYRAL HTN-OFF MED): a randomised, sham-controlled, proof-of-concept trial. Lancet. 2017 Nov 11;390(10108):2160-2170. doi: 10.1016/S0140-6736(17)32281-X. Epub 2017 Aug 28. Kandzari DE, Kario K, Mahfoud F, Cohen SA, Pilcher G, Pocock S, Townsend R, Weber MA, Bohm M. The SPYRAL HTN Global Clinical Trial Program: Rationale and design for studies of renal denervation in the absence (SPYRAL HTN OFF-MED) and presence (SPYRAL HTN ON-MED) of antihypertensive medications. Am Heart J. 2016 Jan;171(1):82-91. doi: 10.1016/j.ahj.2015.08.021. Epub 2015 Sep 11.
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Raymond Townsend, MD
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University of Pennsylvania
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Study protocol
https://cdn.clinicaltrials.gov/large-docs/49/NCT02439749/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/49/NCT02439749/SAP_001.pdf
Results publications and other study-related documents
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Results are available at
https://clinicaltrials.gov/study/NCT02439749
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