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

Not Applicable

Completed

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

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.

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 value
Incidence 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.

Locations (56): Heart Center Research, LLC
🇺🇸
Huntsville, Alabama, United States
Stanford Hospital and Clinics
🇺🇸
Stanford, California, United States
Yale New Haven Hospital
🇺🇸
New Haven, Connecticut, United States
Washington DC VA Medical Center
🇺🇸
Washington D.C., District of Columbia, United States
Baptist Medical Center Jacksonville
🇺🇸
Jacksonville, Florida, United States
Memorial Hospital Jacksonville
🇺🇸
Jacksonville, Florida, United States
Tallahassee Research Institute
🇺🇸
Tallahassee, 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
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Heart Center Research, LLC
🇺🇸Huntsville, Alabama, United States