Uncontrolled Hypertension
Conditions
Keywords
uncontrolled hypertension, renal denervation
Brief summary
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.
Detailed description
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.
Interventions
DEVICERenal denervation (Symplicity Catheter System)
DIAGNOSTIC_TESTRenal angiogram
Sponsors
Medtronic Vascular
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Office Systolic Blood Pressure | Baseline to 6 months post-randomization | Primary Effectiveness Outcome Measure |
Secondary
| Measure | Time frame |
|---|---|
| Change in average 24-hour Systolic Blood Pressure by ambulatory blood pressure monitoring | Baseline to 6 months |
Countries
United States
Outcome results
None listed