Kay Thomas used to take aspirin daily with breakfast. Each dose of this little white pill was supposed to relieve the headaches caused by hypertension, or so she thought. When Thomas didn’t see results, her doctor doubled the dosage. It didn’t relieve her headaches.
Thomas is not alone in her struggle. About 75 million Americans have hypertension, or high blood pressure. According to the Centers for Disease Control and Prevention, nearly one in three adults with hypertension struggle to control their blood pressure despite being on medication. The condition is deceptive, as there are often no noticeable symptoms; thus, hypertension often is untreated. Sometimes, when medications are prescribed, patients don’t consistently take them since they feel fine.
Luckily, potential alternative treatment options are under investigation for those with hypertension. The RADIANCE-HTN Study, a clinical trial sponsored by ReCor Medical, Inc., is evaluating a procedure called renal denervation, which may lower blood pressure and reduce the need for blood pressure medications. The RADIANCE-HTN renal denervation approach utilizes an investigational device which delivers sound waves to calm overactivity of the renal (kidney) nerves, thought to be important in controlling blood pressure levels.
Thomas, who has lived with hypertension for most of her life, decided to participate in the RADIANCE-HTN Study after she discovered it through Facebook.
“I believe (research trials are) the only way we learn (about the value of) technology and learn new techniques, and when I looked into it more … it seemed like a great idea,” Thomas said.
“It may sound cliché, but there is a reason they call hypertension the silent killer,” said Dr. Matheen Khuddus, a hypertension specialist and interventional cardiologist at The Cardiac and Vascular Institute in Gainesville and the site’s principal investigator for the trial. “Most people who have hypertension feel just fine, but the long-term effects of uncontrolled blood pressure and hypertension are significant.”
If left untreated, hypertension can lead to serious health problems, such as heart failure, heart attack, stroke and kidney disease. The RADIANCE-HTN Study is currently on-going in several countries around the world and is evaluating whether high blood pressure can be reduced through renal denervation. The trial offers a minimally-invasive procedure with 7-second ultrasound energy delivery times. Study participants receive care from hypertension specialists and research staff throughout the clinical study, and blood pressure is closely monitored throughout the time of participation in the study.
The study is open to people who, like Thomas, are unable to control their blood pressure or are interested in an alternative to daily medications. “Even if the reduction of the blood pressure is 10 millimeters of mercury, that’s a huge win for a patient that’s on multiple medications and can’t get their blood pressure controlled, or even a patient that’s on one medicine,” Khuddus said.
Although renal denervation is still under investigation, researchers believe studying this potential approach to hypertension treatment is important for the cardiovascular community and for patients with hypertension.
Many people go through life with undiagnosed hypertension, and in some cases, individuals may be misdiagnosed. In Thomas’ case, she was closely monitored by Dr. Khuddus and the specialized research team throughout the study screening process. During the screening phase of the clinical study, Thomas learned that she didn’t have primary hypertension. Rather, her hypertension was secondary to fibromuscular dysplasia, a condition which results in elevated blood pressure.
“I don’t think I would have been properly diagnosed if I hadn’t participated in this study,” Thomas said. “I think if people were more familiar with their treatment options, they might be more open to exploring alternatives to improve their health. In my case, it was an unexpected but valuable opportunity.”
Now Thomas takes the proper medication for her condition, and she no longer has frequent headaches. If you have symptoms of hypertension and are interested in whether you qualify for the RADIANCE-HTN Study, please visit http://highbptrial.com.