SYMPLICITY HTN-3 Renal Denervation in Patients With Uncontrolled Hypertension

Study Overview
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Brief Summary
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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
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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
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Renal Denervation in Patients With Uncontrolled Hypertension (SYMPLICITY HTN-3)

Conditions
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Uncontrolled Hypertension

Intervention / Treatment
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* Device: Renal denervation (Symplicity Catheter System)
* Diagnostic Test: Renal angiogram


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal Denervation<br>Subjects are treated with the renal denervation procedure after randomization and maintained baseline anti-hypertensive medications | Device: Renal denervation (Symplicity Catheter System)<br> <br> Diagnostic Test: Renal angiogram<br> <br> |
| Sham Comparator: Control group<br>Subjects go through renal angiogram and Subjects maintained baseline anti-hypertensive medications | Diagnostic Test: Renal angiogram<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Office Systolic Blood Pressure | Primary Effectiveness Outcome Measure | Baseline to 6 months post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in average 24-hour Systolic Blood Pressure by ambulatory blood pressure monitoring |  | Baseline to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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uncontrolled hypertension, renal denervation