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

Completed · Not applicable · Has a placebo group

Conditions studied: Hypertension, Vascular Diseases, Cardiovascular Diseases

In brief

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.

Key facts

Study ID: NCT01972139
Run by: Medtronic Vascular
People needed: 44
Starts: 2013-10-01
Expected to finish: 2017-01-01
Last updated by the study team: 2017-04-26

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

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

Full record on ClinicalTrials.gov

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