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Providence Enrolls 1st Patient in Landmark Hypertension Treatment Study

Providence Hospital: Southfield
Cardiac Care
Wednesday, February 01, 2012

Providence Enrolls 1st Patient in Landmark Hypertension Treatment Study

Contact: Brian Taylor, 586-753-0726.

Southfield, Mich. – Providence Hospital has enrolled the first patient in Michigan in a national clinical trial of a procedure for treatment-resistant hypertension.

The trial, known as SYMPLICITY HTN-3, is a randomized controlled trial designed to evaluate the safety and effectiveness of renal denervation with Medtronic’s Symplicity Renal Denervation System in patients with treatment-resistant hypertension.

Renal denervation is a minimally invasive, catheter-based procedure that modulates the output of nerves that line the walls of the arteries leading to the kidneys. The targeted nerves are part of the sympathetic nervous system, which has been found to play a central role in blood pressure regulation.

Treatment resistant hypertension, defined as persistently high blood pressure despite three or more antihypertensive medications of different types, puts approximately 120 million people worldwide at risk of premature death from kidney disease and cardiovascular events such as stroke, heart attack and heart failure.

“This treatment could potentially be one of the most important medical breakthroughs in many years,” says Shukri David, M.D, chief of cardiology at Providence Hospital and one of the local principal investigators of the study. “If proven safe and effective in this study, the treatment has the potential to prolong the lives of the millions of people whose lives can be cut short from treatment-resistant hypertension.”

Dr. Susan Steigerwalt, the director of the Resistant Hypertension Laboratory at Providence Hospital is the other co-investigator of the study at Providence.

The study will enroll approximately 530 treatment-resistant hypertension patients across 60 U.S. medical centers. All patients and hypertension follow-up assessors will be blinded to the randomization assignments to remove any potential for bias. The primary endpoints of the study are the change in blood pressure from baseline to six months and incidence of major adverse events up to six months following randomization.

The Symplicity Renal Denervation System consists of a proprietary generator and flexible catheter. The Symplicity catheter is introduced through a separate catheter placed through the skin into the femoral artery, located in the upper thigh, and is then threaded up into the renal artery leading to each kidney. It is connected to the Symplicity generator, which produces low-power radio-frequency (RF) energy.

Once in place within the renal artery, the tip of the Symplicity catheter is placed against the arterial wall in several places where it delivers RF energy to the surrounding sympathetic nerves according to a proprietary, computer-controlled algorithm. The treatment does not involve a permanent implant and is performed under conscious sedation.

The Symplicity Renal Denervation System has been successfully used since 2007 to treat more than 2,000 patients worldwide. It has been commercially available in Europe and Australia since April 2010. The Symplicity System is not approved by the U.S. Food and Drug Administration for commercial distribution in the United States. The FDA granted Medtronic approval for the SYMPLICITY HTN-3 protocol in August of 2011.

Clinical research to date shows that renal denervation with the Symplicity Renal Denervation System may provide a significant and sustained reduction in blood pressure levels for many patients with treatment-resistant hypertension. Published in The Lancet (Dec. 4, 2010), results from SYMPLICITY HTN-2 a randomized, controlled trial of 106 patients in Europe and Australia showed that patients with treatment-resistant hypertension randomized to renal denervation achieved blood pressure reduction at six months, whereas the patients in the control group randomized to anti-hypertensive medications alone had blood pressures that did not vary from their baseline blood pressure. The overall occurrence of adverse events did not differ between groups.

According to the American Heart Association, hypertension is the leading attributable cause of death worldwide. It is a significant, costly and escalating global healthcare problem affecting approximately 1.2 billion people, and is associated with an increased risk of heart attack, stroke, heart failure, kidney disease and death. Among adults aged 40 -70 years old, each increment of 20 mmHg in systolic blood pressure (the top number) or 10 mmHg in diastolic blood pressure (the bottom number) doubles the risk of cardiovascular disease. Hypertension is estimated to have a direct cost to the global healthcare system of more than $500 billion annually. Although pharmaceutical therapy plays a primary role in hypertension management, drugs alone are not effective for all patients. As a result, despite lifestyle changes and the availability of modern antihypertensive agents, approximately 50 percent of patients with hypertension remain uncontrolled and approximately 15-20 percent of those are treatment resistant.

Eligibility Criteria:

  1. Individual is > 18 and ≤ 80 years old at time of randomization.
  2. Individual is receiving a stable medication regimen including full tolerated doses of 3 or more anti-hypertensive medications of different classes, of which one must be a diuretic (with no changes for a minimum of 2 weeks prior to screening) that is expected to be maintained without changes for at least 6 months.
  3. Individual has an office systolic blood pressure (SBP) of > 160 mmHg

Providence Hospital is actively recruiting patients for the trial. Those interested in more information call 1- 248-849-3369.

Providence Hospital is a member of the St. John Providence Health System Heart & Vascular Care Network, a leading provider of heart care in Michigan. Providence has consistently ranked as one of top hospitals in the United States for heart care and is also recognized as Blue Distinction Centers for Cardiac Care by Blue Cross Blue Shield of Michigan.