---
title: Renal Denervation in Patients With Uncontrolled Hypertension - SYMPLICITY HTN-4
nct_id: NCT01972139
overall_status: COMPLETED
phase: NA
sponsor: Medtronic Vascular
study_type: INTERVENTIONAL
primary_condition: Hypertension
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01972139.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01972139"
ct_last_update_post_date: 2017-04-26
last_seen_at: "2026-05-12T06:27:42.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Renal Denervation in Patients With Uncontrolled Hypertension - SYMPLICITY HTN-4

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

**NCT ID:** [NCT01972139](https://clinicaltrials.gov/study/NCT01972139)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 44
- **Lead Sponsor:** Medtronic Vascular
- **Conditions:** Hypertension, Vascular Diseases, Cardiovascular Diseases
- **Start Date:** 2013-10
- **Completion Date:** 2017-01
- **CT.gov Last Update:** 2017-04-26

## Brief Summary

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

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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 80 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Renal Denervation** (EXPERIMENTAL) — Subjects are treated with the renal denervation procedure after randomization.
- **Control** (OTHER) — 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.

## Interventions

- **Renal Denervation using the Symplicity Renal Denervation System** (DEVICE) — Subjects randomized to the renal denervation group underwent angiography and renal denervation.
- **Sham Renal Denervation** (OTHER) — Prior to enrollment closure, subjects were treated with sham renal denervation. After enrollment closure, subjects previously enrolled were no longer eligible to cross-over.
- **Renal Angiography** (DEVICE) — 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.

## Primary Outcomes

- **Reaching BP Goal** _(time frame: 6 months post-randomization)_
- **Incidence of Major Adverse Events through 1 month post-procedure (Renal artery stenosis measured at 6 months)** _(time frame: Baseline to 6 months)_

## Locations (3)

- Piedmont Hospital, Atlanta, Georgia, United States
- Duke University Medical Center, Durham, North Carolina, United States
- Medical University of South Carolina, Charleston, South Carolina, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.piedmont hospital|atlanta|georgia|united states` — added _(2026-05-12)_
- `locations.duke university medical center|durham|north carolina|united states` — added _(2026-05-12)_
- `locations.medical university of south carolina|charleston|south carolina|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01972139.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01972139*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*