(RxWiki News) About 12 percent of patients with hypertension have a resistant form in which blood pressure remains high even while taking several drugs. A new minimally-invasive solution may be on the horizon.
Preliminary results from the phase three investigational SYMPLICITY Renal Denervation System trial indicate that a procedure could lower blood pressure to an acceptable level and keep it there for years.
"Talk to your cardiologist about new methods for managing resistant hypertension."
Dr. Eugene Chung., a lead investigator of the study at The Christ Hospital and medical director of outcomes for the hospital’s Heart and Vascular Center, noted that some resistant hypertension patients already have survived heart attacks or surgical procedures, making blood pressure management that much more critical.
In earlier studies of the procedure, patients were able to reduce their blood pressure by about 30 points, which can make a substantial impact on lowering an increased risk for heart attack and stroke. Researchers noted that each 20 point systolic blood pressure increase doubles the risk of cardiovascular events.
During a procedure with the SYMPLICITY Renal Denervation System, a catheter is inserted into a patient's groin. It is then threaded through to the renal arteries where radiofrequency energy is applied to disrupt sympathetic nerves. The energy prevents neurotransmitters that these nerves released from causing a hormone response responsible for increasing heart rate, constricting blood vessels and raising blood pressure.
The SYMPLICITY Phase III trial is a 90-site national single-blind randomized controlled study that is still underway. Investigators expect to enroll 530 patients with resistant hypertension, assigning them to a treatment or control group. Researchers will monitor patient's blood pressure for six months.
At the end of that six-month period control group participants will also have the opportunity to receive the procedure if it is deemed medically necessary.
SYMPLICITY Phase I and II studies already concluded in Europe and Australia revealed that the procedure reduced blood pressure significantly.