Sham-controlled randomized pilot trial on Baroreflex Activation Therapy (BAT) in resistant hypertension
Individuals with resistant or difficult to treat hypertension has a very high risk for cardiovascular events and premature mortality. These patients do not reach safe blood pressure levels despite adequate lifestyle and pharmacological treatment.
Baroreflex activation therapy (BAT) stimulates baroreceptors – natural sensors in the body that informs the nervous system how to regulate heart, kidney and vascular function. BAT may lower blood pressure in patients with resistant hypertension.
We studied this effect in a randomized, sham-controlled, double blind pilot trial using home and 24-hour blood pressure measurements as endpoints. An implantable BAT device was placed, in the operating room, on one of the carotid arteries in five patients. Participants were randomized to either having the device on or off for eight months. Only the technician was aware of the groups. Thereafter it was activated in all everyone for another eight months. A second randomization was performed 16 months after implantation for three months whereafter all participants were followed for up to five years. No medication changes were done during the trial period. Twenty-four hour blood pressure measurements were done witnessed intake of blood pressure drugs.
Our results show that BAT decreases blood pressure in individuals with difficult to treat hypertension. The results are only suggestive at this time and additional trials are needed to confirm whether this can become a treatment for patients who are at an extremely high risk for cardiovascular events and premature mortality.
Sham-Controlled Randomized Pilot Trial on Baroreflex Activation Therapy in Resistant Hypertension. Simonsen JR, Vikatmaa L, Vikatmaa P, Laine M, Granroth-Wilding H, Groop PH, Tikkanen I, Gordin D. Hypertension 2024; 81:e91-e93.