To comply with FDA standards, the clinical trial is rigorous. Most patients don’t qualify to be candidates. De Marchena said he’s screened more than 80 patients at the UM site but only a handful met the qualifications to participate. Similarly at Baptist, only about one of every 25 patients screened for the trial have been enrolled, said Dr. Alex Powell, the site’s principal investigator.
To participate, patients must be between 18 and 80, and have a systolic blood pressure reading that’s usually more than 160. They must also be taking three or more prescription medications for high blood pressure, including one diuretic, and can’t have a history of major kidney problems.
“The main reason people do not qualify for the trial is the requirement of being on three medications at the maximum dosing levels,” Powell said. “Also, I’ve had several patients who could not take a diuretic. Getting people enrolled is very difficult.”
The study is controlled, which means that some of the enrolled patients will be given a placebo instead of the device, in order to serve as a control group. However, after six months, patients in the control group will be offered the procedure for free if they are interested.
After talking about the trial with her primary care doctor and reading information online, Joseph began the initial candidate tests for the trial. She is currently monitoring her blood pressure every day as part of the screening process.
“I’m really interested in it because I feel like I’m going to get somewhere, finally,” she said. “I would be more than pleased to participate to see if I can get my blood pressure resolved.”