Michael J. Rinaldi, MD, FACC, FSCAI
Director of Clinical Research
At Carolinas HealthCare System's Sanger Heart & Vascular Institute, we're committed to offering patients the most up-to-date care options. Our participation in national clinical trials helps us bring innovative techniques and therapies to those who may have limited treatment options. Sanger is one of 60 centers nationwide involved in a clinical research study, the SYMPLICITY trial, to test the safety and efficacy of a new investigational procedure that treats patients with uncontrollable hypertension—a group of patients who currently have limited treatment options.
Only half of patients with high blood pressure are adequately treated and a segment of this population can't be controlled despite adequate medical and dietary therapy and lifestyle modification. These patients are at increased risk of stroke and renal failure and treatment options have been very limited.
A Minimally Invasive Approach
Interventional cardiologists are now testing a catheter-based procedure to disrupt nerves to the kidneys, called renal sympathetic nerves, using radiofrequency ablation. These nerves, which form a plexus around each renal artery, appear to be important to the regulation of blood pressure. Ablation may result in significant blood pressure reduction. The nerves are accessed through a standard renal angiogram with several treatment sites along each renal artery in a rotating manner.
SYMPLICITY HTN-2 Trial: Catheter-based procedure
to disrupt nerves to the kidney
In the randomized HTN-2 trial, 106 patients with resistant hypertension were treated with renal nerve ablation or sham placebo. This was a resistant population with systolic blood pressure ≥160 mm Hg, and on an average of five medications. Average systolic blood pressure reduction was a remarkable 32 mm Hg at six months follow up, with no major complications or change in renal function. The preceding HTN-1 open-label study suggests blood pressure reduction is maintained beyond two years of follow-up.
Is Your Patient a Candidate?
Patients are eligible to participate if they:
- are between 18 and 85 years old
- have systolic blood pressure consistently ≥160 mm Hg (≥150 mm Hg for patients with type 2 diabetes)
- are taking three or more maximum-dose blood pressure medications, including a diuretic
While this therapy remains investigational in the United States, it's approved in Europe, where thousands of patients have been treated with this technology. The current enrolling SYMPLICITY trial will provide critical data for submission to the U.S. Food and Drug Administration for approval, should preliminary clinical trial results be confirmed. More than 500 patients will be enrolled. Sanger is the only center in the region to have been selected to participate in this exciting study.
According to the American Heart Association, hypertension is a major health burden strongly associated with stroke, heart attack and kidney failure. It's a leading attributable cause of mortality globally, causing approximately 7.5 million deaths each year. If you would like to refer a patient for enrollment in the SYMPLICITY trial, call 704-355-4794.