Renal Denervation in Patients With Uncontrolled Hypertension - SYMPLICITY HTN-4

Study Overview
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Brief Summary
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An international, multi-center, prospective, blinded, randomized, controlled trial. The objective is to demonstrate that catheter-based renal denervation is an effective and safe treatment for uncontrolled hypertension.

Detailed Description
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After the 6 month follow-up required testing has been completed, control group subjects would be unblinded to their randomization group and would have an option, at the discretion of the Investigator and with written concurrence of the medical monitor, to be treated with renal denervation procedure. However, after enrollment closure, subjects previously randomized were no longer allowed to cross-over.

Official Title
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Renal Denervation Using the SYMPLICITY Renal Denervation System in Patients With Uncontrolled Hypertension - SYMPLICITY HTN-4

Conditions
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Hypertension, Vascular Diseases, Cardiovascular Diseases

Intervention / Treatment
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* Device: Renal Denervation using the Symplicity Renal Denervation System
* Other: Sham Renal Denervation
* Device: Renal Angiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individual is on maximally tolerated stable medication regimen including 3 or more anti-hypertensive medications of different classes, one of which must be a thiazide or thiazide-like diuretic Individual has office SBP greater than or equal to 140mmHg and less than 160mmHg Individual has ABPM average SBP greater than or equal to 135 mmHg Exclusion Criteria: Individual lacks appropriate renal artery anatomy Individual has eGFR of less than 30 Individual has Type I diabetes mellitus Individual has had one or more episodes of orthostatic hypotension Individual requires chronic oxygen other than nocturnal respiratory support for sleep apnea Individual has primary pulmonary hypertension Individual has other concomitant conditions that may adversely affect the patient or the study outcomes Individual is pregnant, nursing or planning to be pregnant Individual has had a previous organ transplant

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. | Device: Renal Denervation using the Symplicity Renal Denervation System<br>* Subjects randomized to the renal denervation group underwent angiography and renal denervation.<br>Device: Renal Angiography<br>* Subjects who met all criteria after the screening period did undergo a renal artery angiogram to evaluate renal artery anatomy. Only subjects with eligible renal artery anatomy were randomized.<br>|
| Other: Control<br>Subjects randomized prior to enrollment closure were treated with sham renal denervation (angiography only). Once enrollment was closed and the protocol revised, no control subjects crossed-over. | Other: Sham Renal Denervation<br>* Prior to enrollment closure, subjects were treated with sham renal denervation. After enrollment closure, subjects previously enrolled were no longer eligible to cross-over.<br>Device: Renal Angiography<br>* Subjects who met all criteria after the screening period did undergo a renal artery angiogram to evaluate renal artery anatomy. Only subjects with eligible renal artery anatomy were randomized.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reaching BP Goal |  | 6 months post-randomization | 
| Incidence of Major Adverse Events through 1 month post-procedure (Renal artery stenosis measured at 6 months) |  | 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, blood pressure, renal denervation, HTN-4, SYMPLICITY