Patients who have unsuccessfully tried to control high blood pressure with medication may now have a new option at Florida Hospital Pepin Heart Institute. The hospital is now enrolling patients in a new clinical research study called CONTROL HyperTeNsion (HTN)-2. This innovative study is designed to evaluate the safety and effectiveness of a device called the ROX Coupler, which is used to relieve pressure in a patient’s arteries by diverting blood from the arteries into the veins. Florida Hospital Pepin Heart Institute is one of only two hospitals in Florida participating in the trial, and the only one in the Tampa Bay area.
The ROX Coupler is a small device that is inserted percutaneously; meaning that small incisions are made, and thin catheters are inserted in the artery and vein, through which the ROX Coupler is deployed. The ROX Coupler creates a passage between the iliac artery and iliac vein in pelvic area, redirecting a measured amount of blood from the artery to the vein. This minimally invasive procedure is performed in a cardiac catheterization lab or hybrid operating room.
“As blood pressure increases, the risks of stroke, heart attack, heart failure and kidney failure also increase. Lowering blood pressure even a small amount reduces that risk,” says Charles Lambert, MD, Medical Director of Florida Hospital Pepin Heart Institute. “The ROX Coupler is designed to divert a controlled amount of blood from the high-pressure arteries to the lower-pressure veins. This approach has great potential to help patients who don’t respond well to blood pressure medication.”
According to the American Heart Association, high blood pressure, also called hypertension, affects more than 100 million adults in the United States. Only about half of them successfully control their high blood pressure with medications and lifestyle changes.
To be eligible for the ROX CONTROL HTN-2 clinical trial, patients should currently be taking three or more blood pressure medications every day and still have systolic pressure (the top number in a blood pressure reading) greater than 155 mmHg. The CONTROL HTN-2 study is a multi-center randomized trial that will include 30 study sites in the United States.
In a previous trial in Europe, patients treated with the ROX Coupler experienced a mean drop in blood pressure of 27 mmHg, which was sustained out to 12 months.
“Clinical trials allow us to offer potentially lifesaving breakthroughs before they are available in many other hospitals,” says Elizabeth Kohl, MS, MPH, CCRP, Director of the Dr. Kiran C. Patel Research Institute at Florida Hospital Pepin Heart Institute. “These leading-edge therapies provide advanced medical options for our patients while furthering scientific knowledge in the prevention, treatment, and management of cardiovascular disease. We are excited to partner with ROX Medical to bring this important advancement to our community.”
For more information about the ROX CONTROL HTN-2 clinical trial, visit controlhtn2.com or clinicaltrials.gov/ct2/show/NCT02895386. To find out if you qualify for the trial, call (813) 610-8110 or e-mail firstname.lastname@example.org.