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SYMPLICITY HTN-3 Renal Denervation in Patients With Uncontrolled Hypertension
Not Recruiting
Trial ID: NCT01418261
Purpose
The Symplicity HTN-3 study is a, multi-center, prospective, single-blind, randomized,
controlled study of the safety and effectiveness of renal denervation in subjects with
uncontrolled hypertension. Bilateral renal denervation will be performed using the Symplicity
Catheter - a percutaneous system that delivers radiofrequency (RF)energy through the luminal
surface of the renal artery.
Official Title
Renal Denervation in Patients With Uncontrolled Hypertension (SYMPLICITY HTN-3)
Eligibility
Inclusion Criteria:
- Individual is ≥ 18 and ≤ 80 years old at time of randomization.
- Individual is receiving a stable medication regimen including full tolerated doses of
3 or more anti-hypertensive medications of different classes, of which one must be a
diuretic (with no changes for a minimum of 2 weeks prior to screening) that is
expected to be maintained without changes for at least 6 months.
- Individual has an office systolic blood pressure (SBP) of ≥ 160 mmHg based on an
average of 3 blood pressure readings measured at both an initial screening visit and a
confirmatory screening visit
Exclusion Criteria:
- Individual has an estimated glomerular filtration rate (eGFR) of < 45 mL/min/1.73 m2
- Individual has an Ambulatory Blood Pressure Monitoring (ABPM) 24 hour average SBP <
135 mmHg
- Individual has type 1 diabetes mellitus
- Individual requires chronic oxygen support or mechanical ventilation (e.g.,
tracheostomy, CPAP, BiPAP) other than nocturnal respiratory support for sleep apnea.
- Individual has primary pulmonary hypertension.
- Individual is pregnant, nursing or planning to be pregnant.
Intervention(s):
device: Renal denervation (Symplicity Catheter System)
diagnostic test: Renal angiogram
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Maria Perlas
650-723-2094