03:32pm Wednesday 21 August 2019

Brigham and Women’s Hospital Enrolls First Patient in Landmark Study of Novel Approach to Treat Resistant Hypertension

BWH is the first in New England to enroll a patient in this study and one of few hospitals participating in the study in the region.

“Despite advances in anti-hypertensive medications, many patients still have uncontrolled high blood pressure, placing them at risk for kidney disease and cardiovascular disease, including heart attacks, heart failure, and stroke,” said Mark Creager, MD, cardiologist at BWH and Co-Principal Site Investigator.

Twenty-five percent of Americans have hypertension and according to the World Heart Federation, treatment-resistant hypertension, defined as systolic blood pressure that remains high (greater than 140/90 mmHg) despite treatment with three or more antihypertensive medications, poses a serious health threat to nearly six million Americans and 100 million people worldwide.

SYMPLICITY HTN-3 is a multi-center, single-blind, randomized, controlled study evaluating the safety and effectiveness of renal denervation in subjects with treatment-resistant hypertension. Patients are randomized to receive either bilateral renal denervation with current medications or maintain baseline anti-hypertensive medications. Bilateral renal denervation is performed using a percutaneous catheter system that delivers radiofrequency (RF) energy through the luminal surface of the renal artery. The therapy is designed to control the nerves that line the walls of the arteries leading to the kidneys and regulate the communication between these nerves and the brain. Part of the sympathetic nervous system, these targeted nerves are believed to play a central role in blood pressure regulation. All patients are monitored for six months during which researchers will measure the change in blood pressure and record any incidence of major adverse events.

The study will enroll approximately 530 treatment-resistant hypertension patients across several US medical centers and the principal investigator for the entire study is Depak Bhatt, MD, MPH chief of Cardiology at VA Boston Healthcare System and director of the Integrated Interventional Cardiovascular Program at BWH.  BWH was selected in part because of the strong commitment to clinical research and for the advanced, multidisciplinary program that has been developed to care for patients with hypertension.

“This minimally invasive procedure represents a novel approach to treating patients with refractory hypertension,” said Piotr S. Sobieszczyk, MD, BWH Site Co-Principal Investigator and Associate Director of the Cardiac Catheterization Laboratory at Brigham and Women’s Hospital. “The design of the study is also unique because patients in the study who do not initially receive the procedure will be eligible to receive the procedure if they choose to after the study’s mandated observation period.”

For more information about the SYMPLICITY HTN-3 study, please contact Jonah Zuflacht at (617) 732-6320 or jzuflacht@partners.org.

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