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

Not Applicable

Completed

• Conditions: Vascular Diseases; Cardiovascular Diseases; Hypertension

• Registration Number: NCT01972139
• Lead Sponsor: Medtronic Vascular

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.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-22
• Study First Submitted QC: 2013-10-24
• Study First Posted: 2013-10-30
• Primary Completion: 2014-07
• Disposition First Submitted: 2014-09-15
• Disposition First Submitted QC: 2014-09-15
• Disposition First Posted: 2014-09-29
• Study Completion: 2017-01
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-24
• Last Update Posted: 2017-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of Major Adverse Events through 1 month post-procedure (Renal artery stenosis measured at 6 months)	Baseline to 6 months
Reaching BP Goal	6 months post-randomization

Trial Locations

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