NEW YORK, NEW YORK (October 25, 2012) -- Patients with hypertension whose blood pressure cannot be brought down to safe levels despite taking three or more medications may have some relief coming their way. An innovative, first-of-its-kind clinical trial for a device representing a dramatic shift in treatment approaches for the toughest-to-treat patients is currently being conducted at NewYork-Presbyterian Hospital.
Clinical trials of the Symplicity renal denervation system from Medtronic are underway at both NewYork-Presbyterian Hospital/Weill Cornell Medical Center and NewYork-Presbyterian Hospital/Columbia University Medical Center, which is the leading clinical-trial site in metropolitan New York. If successful, this investigational procedure -- which deviates from traditional pharmaceutical therapies in favor of a minimally invasive procedure that aims to down-regulate overactive nerves in the body that can cause rising blood pressure -- could turn the tide for the many Americans affected by treatment-resistant hypertension.
"Hypertension is a serious health problem, and those with drug-resistant hypertension are at the greatest risk of developing organ damage, including heart attack, stroke and death," says Dr. Ajay J. Kirtane, an interventional cardiologist and chief academic officer of the Center for Interventional Vascular Therapy at NewYork-Presbyterian/Columbia University Medical Center. Dr. Kirtane is leading the study at NewYork-Presbyterian/Columbia. "In earlier studies, the Symplicity renal denervation system reduced systolic blood pressure by an average of 33 millimeters, a remarkable amount for patients with such severe hypertension. If the results are duplicated in this pivotal clinical trial, we may have discovered an effective treatment that will help millions of Americans."
"The Symplicity renal denervation system may someday be an attractive alternative for patients in the U.S. who have uncontrolled hypertension despite treatment with many medications," says Dr. Samuel J. Mann, a leading hypertension specialist at NewYork-Presbyterian/Weill Cornell and professor of clinical medicine at Weill Cornell Medical College, who is leading the study at NewYork-Presbyterian/Weill Cornell.
Researchers think that hyperactivity of the sympathetic nervous system, which connects the brain, heart, blood vessels and kidneys -- each of which plays an important role in blood pressure -- contributes to resistant hypertension. The Simplicity renal denervation system seeks to reduce the drive of the sympathetic nervous system by preventing it from sending out erroneous signals to the brain to increase blood pressure.
In the Symplicity system, a catheter is introduced through a very small incision in the groin and is threaded up into the renal arteries that supply blood to the kidneys. Once in place, the catheter sends out radio waves at a preset frequency generated by a proprietary generator, which target the sympathetic nerves without damaging the surrounding blood vessels. The catheter is removed once the radiofrequency waves have been delivered at multiple locations along the artery.
Affecting about 76.4 million people over the age of 20 nationwide, hypertension is a common cardiovascular disorder in which blood-pressure levels are abnormally elevated -- systolic blood pressure of 140 or greater or diastolic blood pressure of 90 or greater -- over a sustained period of time. Hypertension is considered to be treatment-resistant when a patient's blood pressure remains high despite treatment with three or more antihypertensive medications.
The U.S. Food and Drug Administration approved the Symplicity HTN-3 study protocol in July 2011. NewYork-Presbyterian Hospital is currently enrolling patients for the study, which altogether will randomize 530 patients to receive either renal denervation combined with antihypertensive medications or treatment with antihypertensive medications alone. To qualify, patients must meet certain criteria, including having systolic blood pressure of at least 160 mmHg in the physicians's office despite treatment with adequate doses of at least three antihypertensive medications.
To enroll in the study at NewYork-Presbyterian/Columbia, call the Department of Surgery at (212) 342-1820. To enroll in the study at NewYork-Presbyterian/Weill Cornell, call the Department of Medicine at (212) 746-6112.
Columbia University Medical Center
Columbia University Medical Center provides international leadership in basic, pre-clinical and clinical research, in medical and health sciences education, and in patient care. The Medical Center trains future leaders and includes the dedicated work of many physicians, scientists, public health professionals, dentists, and nurses at the College of Physicians & Surgeons, the Mailman School of Public Health, the College of Dental Medicine, the School of Nursing, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. Established in 1767, Columbia's College of Physicians and Surgeons was the first institution in the country to grant the M.D. degree and is now among the most selective medical schools in the country. Columbia University Medical Center is home to the largest medical research enterprise in New York City and state and one of the largest in the United States. For more information, please visit www.cumc.columbia.edu.
NewYork-Presbyterian Hospital/Weill Cornell Medical Center
NewYork-Presbyterian Hospital/Weill Cornell Medical Center, located in New York City, is one of the leading academic medical centers in the world, comprising the teaching hospital NewYork-Presbyterian and Weill Cornell Medical College, the medical school of Cornell University. NewYork-Presbyterian/Weill Cornell provides state-of-the-art inpatient, ambulatory and preventive care in all areas of medicine, and is committed to excellence in patient care, education, research and community service. Weill Cornell physician-scientists have been responsible for many medical advances -- including the development of the Pap test for cervical cancer; the synthesis of penicillin; the first successful embryo-biopsy pregnancy and birth in the U.S.; the first clinical trial for gene therapy for Parkinson's disease; the first indication of bone marrow's critical role in tumor growth; and, most recently, the world's first successful use of deep brain stimulation to treat a minimally conscious brain-injured patient. NewYork-Presbyterian Hospital also comprises NewYork-Presbyterian Hospital/Columbia University Medical Center, NewYork-Presbyterian/Morgan Stanley Children's Hospital, NewYork-Presbyterian Hospital/Westchester Division and NewYork-Presbyterian/The Allen Hospital. NewYork-Presbyterian is the #1 hospital in the New York metropolitan area and is consistently ranked among the best academic medical institutions in the nation, according to U.S.News & World Report. Weill Cornell Medical College is the first U.S. medical college to offer a medical degree overseas and maintains a strong global presence in Austria, Brazil, Haiti, Tanzania, Turkey and Qatar. For more information, visit www.nyp.org and weill.cornell.edu.
NewYork-Presbyterian Hospital, based in New York City, is the nation's largest not-for-profit, non-sectarian hospital, with 2,409 beds. The Hospital has nearly 2 million inpatient and outpatient visits in a year, including 12,797 deliveries and 195,294 visits to its emergency departments. NewYork-Presbyterian's 6,144 affiliated physicians and 19,376 staff provide state-of-the-art inpatient, ambulatory and preventive care in all areas of medicine at five major centers: NewYork-Presbyterian Hospital/Weill Cornell Medical Center, NewYork-Presbyterian Hospital/Columbia University Medical Center, NewYork-Presbyterian/Morgan Stanley Children's Hospital, NewYork-Presbyterian/The Allen Hospital and NewYork-Presbyterian Hospital/Westchester Division. One of the most comprehensive health care institutions in the world, the Hospital is committed to excellence in patient care, research, education and community service. NewYork-Presbyterian is the #1 hospital in the New York metropolitan area and is consistently ranked among the best academic medical institutions in the nation, according to U.S. News & World Report. The Hospital has academic affiliations with two of the nation's leading medical colleges: Weill Cornell Medical College and Columbia University College of Physicians and Surgeons. For more information, visit www.nyp.org.
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