Trial Search Results
SPYRAL HTN-ON MED Study
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.
Stanford is currently accepting patients for this trial.
- Device: Symplicity Spyral™ multi-electrode renal denervation system
- Procedure: Sham Procedure
- 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.
Ages Eligible for Study
20 Years - 80 Years
Genders Eligible for Study