Hypertension, Vascular Diseases, Cardiovascular Diseases
Conditions
Keywords
Uncontrolled hypertension, blood pressure, renal denervation, HTN-4, SYMPLICITY
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.
Interventions
DEVICERenal Denervation using the Symplicity Renal Denervation System
Subjects randomized to the renal denervation group underwent angiography and renal denervation.
OTHERSham Renal Denervation
Prior to enrollment closure, subjects were treated with sham renal denervation. After enrollment closure, subjects previously enrolled were no longer eligible to cross-over.
DEVICERenal Angiography
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.
Sponsors
Medtronic Vascular
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed