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

Medtronic

Status: Completed

Conditions: Hypertension; Cardiovascular Diseases; Vascular Diseases

Treatments: Other: Sham Renal Denervation; Device: Renal Denervation using the Symplicity Renal Denervation System; Device: Renal Angiography

Study type: Interventional

Funder types: Industry

Identifiers

NCT01972139

HTN-4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups

Renal Denervation

Experimental group

Description:

Subjects are treated with the renal denervation procedure after randomization.

Treatment:

Device: Renal Angiography

Device: Renal Denervation using the Symplicity Renal Denervation System

Control

Other group

Description:

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.

Treatment:

Other: Sham Renal Denervation

Device: Renal Angiography