Newswise — CINCINNATI, Ohio—A radically different approach to treating high blood pressure – using a minimally invasive procedure– is being evaluated as part of a Pivotal Phase III 90-site national trial that includes The Carl H. and Edyth Lindner Center for Research and Education at The Christ Hospital.
Resistant hypertension affects more than 12 percent of patients who take anti-hypertensive medications to manage the condition. Despite being on three or more medications, these patients have blood pressure that remains high enough to put them at risk for heart attack or stroke. For every 20 point increase in systolic pressure, the risk of cardiovascular episodes doubles, according to The Christ Hospital cardiology researchers.
“Some patients who have resistant hypertension may already be survivors of heart attacks or have undergone surgery, making their blood pressure management that much more critical,” said Eugene Chung, M.D., a lead investigator of the study at The Christ Hospital and medical director of outcomes for the hospital’s Heart and Vascular Center.
In earlier studies, patients who underwent this minimally invasive procedure were able to reduce their pressure by about 30 or so points. The positive earlier trial results warranted further study.
The investigational SYMPLICITY™ Renal Denervation System® includes inserting a catheter at the groin and advancing it to the renal arteries where radiofrequency (RF) energy is delivered that disrupts sympathetic nerves around the renal arteries. This prevents neurotransmitters released by these nerves from triggering a hormone response that increases heart rate, constricts blood vessels and raises blood pressure. It is similar to an ablation procedure technique typically used for atrial fibrillation treatment. The application to the sympathetic nerves is novel in the U.S. In earlier SYMPLICITY Phase I and II studies conducted in Europe and Australia, results indicated that the procedure reduced blood pressure significantly.
“Preliminary results suggest that patients need only one such treatment to achieve optimal results, and these results can last for years, significantly decreasing the odds for these higher-risk patients of experiencing a serious heart attack or stroke,” said Dean Kereiakes, M.D., also a lead investigator on the study at The Christ Hospital and medical director of The Christ Hospital Heart and Vascular Center, as well as The Carl and Edyth Lindner Center for Research and Education.
The SYMPLICITY Phase III trial is a prospective, single-blind, randomized, controlled trial that will enroll approximately 530 patients in up to 90 research sites nationwide. Those enrolled will be assigned randomly to either treatment or control groups at a 2:1 ratio. Patients’ blood pressure will be monitored for six months. Researchers will track and report any major adverse events, including death, end-stage renal disease, or organ damage. After six months, patients in the control group will be allowed to receive the RF procedure if deemed clinically necessary.
In the United States alone, it is estimated that one in every three adults, or about 65 million, have high blood pressure, and many more are at risk of developing it.
For more information about SYMPLICITY and enrollment requirements, please contact The Lindner Research Center at 513-585-1777. Patients can also visit www.simplifybptrial.com for more information about the clinical trial. About The Lindner Research Center: For the past 25 years, The Carl and Edyth Lindner Center for Research and Education (Lindner Research Center) has provided leading-edge medicines and medical technology research covering a broad spectrum of conditions from obesity, diabetes, coronary disease, hypertension and hyperlipidemia to new vascular interventional devices, adult stem cell therapies, structural heart disease, cardiovascular surgery, heart failure and electrophysiology. Physicians at the Lindner Research Center have conducted more than 1,200 clinical trials including multiple first-in-man and first-in-the-U.S procedures, which have contributed to best practice standards for the care of patients. For information on current trials, please call 513-585-1777. About The Christ Hospital: The Christ Hospital offers a wide range of medical, surgical and testing services at its main campus just north of Downtown Cincinnati and at numerous outpatient and physician practice locations throughout Greater Cincinnati. Its mission is to provide the finest patient experience and improve the health of our community. For the past 12 years, The Christ Hospital has been recognized by U.S. News & World Report as one of the nation’s top hospitals, and has been named Cincinnati’s Most Preferred Hospital for 16 consecutive years by National Research Corporation (NRC). The Christ Hospital has been granted Magnet® recognition from the American Nurses Credentialing Center for excellence in nursing care. For more information about the award-winning services of The Christ Hospital, visit www.TheChristHospital.com.
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