SPYRAL HTN-ON MED Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System
- Conditions
- Cardiovascular DiseasesHypertensionVascular Diseases
- Interventions
- Procedure: Sham ProcedureDevice: Symplicity Spyral™ multi-electrode renal denervation system
- Registration Number
- NCT02439775
- 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 presence of up to three standard antihypertensive medications.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 337
- 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.
- 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 Sham Procedure Sham Procedure Renal angiography Renal Denervation Symplicity Spyral™ multi-electrode renal denervation system Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)
- Primary Outcome Measures
Name Time Method Change in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM) 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).
Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events 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).
- Secondary Outcome Measures
Name Time Method Antihypertensive Medication Burden to 6-months 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 valueIncidence of Achieving Target Office Systolic Blood Pressure From baseline to 6 months post-procedure Incidence of achieving target office systolic blood pressure (SBP\<140 mmHg) at 6 months post- procedure.
Change in Office Systolic Blood Pressure 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 From baseline to 6-month post-procedure Number of medications from baseline (Screening Visit 2) through 6 Months post-procedure
Medication Changes 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.
Trial Locations
- Locations (56)
Cardiology Associates Research LLC
🇺🇸Tupelo, Mississippi, United States
Tallahassee Research Institute
🇺🇸Tallahassee, Florida, United States
Providence Hospital
🇺🇸Southfield, Michigan, United States
Hattiesburg Clinic
🇺🇸Hattiesburg, Mississippi, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
AnMed Health
🇺🇸Anderson, South Carolina, United States
Charleston Area Medical Center
🇺🇸Charleston, West Virginia, United States
Stanford Hospital and Clinics
🇺🇸Stanford, California, United States
Washington DC VA Medical Center
🇺🇸Washington, District of Columbia, United States
Yale New Haven Hospital
🇺🇸New Haven, Connecticut, United States
Memorial Hospital Jacksonville
🇺🇸Jacksonville, Florida, United States
Emory University Hospital Midtown
🇺🇸Atlanta, Georgia, United States
Piedmont Heart Institute
🇺🇸Atlanta, Georgia, United States
Iowa Heart Center
🇺🇸West Des Moines, Iowa, United States
St Joseph Mercy Oakland
🇺🇸Pontiac, Michigan, United States
Saint Barnabas Medical Center
🇺🇸Livingston, New Jersey, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
PinnacleHealth Cardiovascular Institute
🇺🇸Harrisburg, Pennsylvania, United States
Centennial Medical Center
🇺🇸Nashville, Tennessee, United States
Baylor Heart & Vascular Hospital
🇺🇸Dallas, Texas, United States
Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
St. George Hospital
🇦🇺Kogarah, Australia
Clinique Pasteur
🇫🇷Toulouse, France
Hamilton Heath
🇨🇦Hamilton, Ontario, Canada
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Universitätsklinikum Erlangen
🇩🇪Erlangen, Germany
University General Hospital of Thessaloniki (AHEPA)
🇬🇷Thessaloniki, Greece
Sana Kliniken Lübeck
🇩🇪Lübeck, Germany
Hippokration General Hospital of Athens
🇬🇷Athens, Greece
Higashi Takarazuka Satoh Hospital
🇯🇵Takarazuka, Hyogo, Japan
Jichi Medical University Hospital
🇯🇵Shimotsuke, Tochigi, Japan
Cardiff and Vale University Health Board - University Hospital of Wales
🇬🇧Cardiff, United Kingdom
Saiseikai Nakatsu Hospital
🇯🇵Osaka, Japan
Royal Bournemouth Hospital
🇬🇧Bournemouth, United Kingdom
Royal Devon & Exeter NHS Foundation Trust
🇬🇧Exeter, United Kingdom
Universitäts-Herzzentrum Freiburg - Bad Krozingen GmbH
🇩🇪Bad Krozingen, Germany
Herzzentrum Leipzig, Universitätsklinik
🇩🇪Leipzig, Germany
Universitätsklinikum des Saarlandes
🇩🇪Homburg, Germany
Oregon Health & Science University Hospital
🇺🇸Portland, Oregon, United States
Aurora St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Royal Perth
🇦🇺Perth, Australia
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
Weill Cornell Medical College/The New York Presbyterian Hospital
🇺🇸New York, New York, United States
Baptist Medical Center Jacksonville
🇺🇸Jacksonville, Florida, United States
Heart Center Research, LLC
🇺🇸Huntsville, Alabama, United States
Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
Shonan Kamakura General Hospital
🇯🇵Kamakura City, Okamoto, Japan
Galway University Hospital
🇮🇪Galway, Ireland
Imperial College Healthcare NHS Trust
🇬🇧London, United Kingdom
University of Kentucky
🇺🇸Lexington, Kentucky, United States
The Miriam Hospital
🇺🇸Providence, Rhode Island, United States
Klinikum Wels-Grieskirchen
🇦🇹Wels, Austria
Mitsui Memorial Hospital
🇯🇵Chiyoda, Tokyo, Japan