SPYRAL PIVOTAL - SPYRAL HTN-OFF MED Study
- Conditions
- HypertensionVascular DiseasesCardiovascular Diseases
- Interventions
- Device: Symplicity Spyral™ multi-electrode renal denervation systemProcedure: Sham Procedure
- Registration Number
- NCT02439749
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 366
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Renal Denervation Symplicity Spyral™ multi-electrode renal denervation system Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Sham Procedure Sham Procedure Renal angiography
- Primary Outcome Measures
Name Time Method Number of Participants With Major Adverse Events (MAE) Defined as a Composite of Events. From baseline to 1 month post-procedure (6 months for new renal artery stenosis) 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)
Baseline Adjusted Change (Using Analysis of Covariance) in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring 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
Name Time Method New Stroke From baseline to 3 months post randomization Number of Participants with New Stroke
Number of Participants With Renal Artery Re-intervention From baseline to 36 months post randomization Renal Artery Re-intervention
Number of Participants With Major Bleeding According to TIMI Definition From baseline to 36 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).
Number of Participants With Increase in Serum Creatinine From baseline to 1 month post-procedure Increase in serum creatinine \> 50% from screening visit 2.
Number of Participants With Hospitalization for Hypertensive Crisis With Medications or the Protocol From baseline to 1 month post-procedure Hospitalization for hypertensive crisis not related to confirmed non-adherence with medications or the protocol.
Change in Office Systolic Blood Pressure From baseline to 36 months post procedure Change in Office Systiloc Blood Pressure From Baseline (Screening Visit 2) to 36 months.
Change in Office Diastolic Blood Pressure From baseline to 36 months post-procedure Change in office diastolic blood pressure
Number of Participants Achieving Target Office Systolic Blood Pressure From baseline to 3 months post procedure Incidence of Achieving Target Office Systolic Blood Pressure (SBP \<140 mmHg)
Baseline Adjusted Change (Using Analysis of Covariance) in Office Systolic Blood Pressure 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.
Number of Participants With All-cause Mortality From baseline to 36 months post-randomization Number of Participants With ≥40% Decline in eGFR From baseline to 36 months post randomization ≥40% Decline in eGFR
Number of Participants With End-Stage Renal Disease (ESRD) From baseline to 36 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, vomitingNumber of Participants With New Myocardial Infarction From baseline to 36 months post randomization New Myocardial Infarction
Increase in Serum Creatinine From baseline to 3 months post randomization Number of Participants with Increase in Serum Creatinine \> 50% from screening visit 2.
Number of Participants With Hospitalization for Hypertensive Crisis From baseline to 36 months post randomization Hospitalization for hypertensive crisis not related to confirmed non-adherence with medications orthe protocol
Change in Diastolic Blood Pressure as Measured by 24-hour ABPM From baseline to 36 months post-procedure Change in diastolic blood pressure as measured by 24-hour ABPM
Number of Participants With New Renal Artery Stenosis > 70% From baseline to 36 months post randomization Confirmed by angiography and as determined by the angiographic core laboratory.
Change in Systolic Blood Pressure as Measured by 24-hour ABPM From baseline to 36 month post-procedure Number of Participants With Incidence of Achieving Target Office Systolic Blood Pressure (SBP <140) mmHg) From baseline to 36 months post-procedure Number of Participants With New Stroke From baseline to 36 months post randomization New Stroke
Number of Participants With an Increase in Serum Creatinine From baseline to 36 months post randomization Number of Participants with Increase in Serum Creatinine \> 50% from screening visit 2.
Number of Participants With Significant Embolic Event Resulting in End-organ Damage 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)
Number of Participants With Renal Artery Perforation Requiring Intervention From baseline to 1 month post-procedure Renal artery perforation requiring intervention
Renal Artery Dissection From baseline to 1 month post-procedure Number of Participants with Renal artery dissection requiring intervention
Number of Participants With Vascular Complications 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).
Number of Participants With End-stage Renal Disease 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, vomitingNumber of Participants With Decline in eGFR From baseline to 1 month post-procedure ≥40% decline in eGFR
Myocardial Infarction From baseline to 1 month post-procedure Number of Participants with New myocardial infarction
Trial Locations
- Locations (47)
Saint Barnabas Medical Center
🇺🇸Livingston, New Jersey, United States
Tallahassee Research Institute
🇺🇸Tallahassee, Florida, United States
Klinikum Wels-Grieskirchen
🇦🇹Wels, Austria
Universitätsklinikum des Saarlandes
🇩🇪Homburg, Germany
Emory University Hospital Midtown
🇺🇸Atlanta, Georgia, United States
Piedmont Heart Institute
🇺🇸Atlanta, Georgia, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Mitsui Memorial Hospital
🇯🇵Chiyoda, Tokyo, Japan
University of Kentucky
🇺🇸Lexington, Kentucky, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Galway University Hospital
🇮🇪Galway, Ireland
The Miriam Hospital
🇺🇸Providence, Rhode Island, United States
Royal Devon & Exeter NHS Foundation Trust
🇬🇧Exeter, United Kingdom
Heart Center Research, LLC
🇺🇸Huntsville, Alabama, United States
Honor Health Research Institute
🇺🇸Scottsdale, Arizona, United States
Stanford Hospital and Clinics
🇺🇸Stanford, California, United States
Kaiser Permanente LA Medical Center
🇺🇸Los Angeles, California, United States
Baptist Medical Center Jacksonville
🇺🇸Jacksonville, Florida, United States
Iowa Heart Center
🇺🇸West Des Moines, Iowa, United States
St Joseph Mercy Oakland
🇺🇸Pontiac, Michigan, United States
Hattiesburg Clinic
🇺🇸Hattiesburg, Mississippi, United States
Providence Hospital
🇺🇸Southfield, Michigan, United States
Cardiology Associates Research LLC
🇺🇸Tupelo, Mississippi, United States
Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
PinnacleHealth Cardiovascular Institute
🇺🇸Harrisburg, Pennsylvania, United States
AnMed Health
🇺🇸Anderson, South Carolina, United States
Baylor Heart & Vascular Hospital
🇺🇸Dallas, Texas, United States
Charleston Area Medical Center
🇺🇸Charleston, West Virginia, United States
Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Institut de cardiologie de Montréal / Montreal Heart Institute
🇨🇦Montréal, Quebec, Canada
Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH
🇩🇪Bad Krozingen, Germany
Universitätsklinikum Erlangen
🇩🇪Erlangen, Germany
Hippokration General Hospital of Athens
🇬🇷Athens, Greece
Sana Kliniken Lübeck
🇩🇪Lübeck, Germany
Herzzentrum Leipzig, Universitätsklinik
🇩🇪Leipzig, Germany
University General Hospital of Thessaloniki (AHEPA)
🇬🇷Thessaloniki, Greece
Imperial College Healthcare NHS Trust
🇬🇧London, United Kingdom
Cardiff and Vale University Health Board - University Hospital of Wales
🇬🇧Cardiff, United Kingdom
Jichi Medical University Hospital
🇯🇵Shimotsuke, Tochigi, Japan
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Centennial Medical Center
🇺🇸Nashville, Tennessee, United States
Aurora St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States