SPYRAL HTN-ON MED Study

Trial ID or NCT#

NCT02439775

Status

recruiting iconRECRUITING

Purpose

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.

Official Title

Global Clinical Study of Renal Denervation With the Symplicity Spyral™ Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension on Standard Medical Therapy (SPYRAL HTN-ON MED)

Eligibility Criteria

Ages Eligible for Study: 20 Years to 80 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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.

Investigator(s)

Alan Yeung, MD
Alan Yeung, MD
Interventional cardiologist, Cardiologist
Li Ka Shing Professor in Cardiology
David Lee, MD
David Lee, MD
Cardiologist, Interventional cardiologist
Professor of Medicine (Cardiovascular Medicine)

Contact us to find out if this trial is right for you.

Contact

Maria E Perlas
650-723-2094