Naomi D. Fisher, MD, Director of the Hypertension Specialty Clinic in the Division of Endocrinology, Diabetes and Hypertension, and Laura Mauri, MD, MSc, Director of Center for Clinical Biometrics in the Division of Cardiovascular Medicine, are collaborating on innovative approaches for the treatment of hypertension.
Dr. Fisher, Dr. Mauri and Piotr S. Sobieszczyk, MD, of the Division of Cardiovascular Medicine, are currently enrolling participants for a randomized, double-blind study called the ReCor Medical Paradise System in Clinical Hypertension (Radiance-HTN) study, designed to demonstrate efficacy and safety of the Paradise Renal Denervation System in two populations of hypertensive patients.
“Many physicians think that renal nerve ablation is no longer a viable option, but treating high blood pressure with renal denervation is still very promising,” said Dr. Fisher, principal investigator of the study which began in March 2016.
A total of 292 patients with a documented history of essential hypertension will receive the renal denervation procedure using The Paradise® Renal Denervation System, a minimally invasive procedure that delivers ultrasound energy to thermally ablate and disrupt the renal sympathetic nerves while sparing the renal arterial wall. A diagnostic renal angiogram will be considered the sham procedure for control participants.
The primary outcome measure of the Radiance-HTN study is the reduction of average daytime ambulatory systolic blood pressure two months following ultrasound renal denervation. The study will also track 13 additional secondary outcomes measures, including hospitalization for heart failure, acute myocardial infarction, and renal artery or vascular complications requiring intervention.
Final data collection for the primary outcome measure – mean reduction in average daytime ambulatory systolic blood pressure – is estimated to end in August 2017, and the study completion date is scheduled for July 2020. (For more information on Radiance-HTN, contact Dr. Fisher at nfisher@partners.org or 617-732-5666).
Dr. Fisher is also collaborating with researcher Gordon Williams, MD, within the Division of Endocrinology, Diabetes and Hypertension, on a translational research study called the Hypertension Pathotype (HyperPATH), which aims to identify the genetic underpinnings of hormonal factors that lead to hypertension.
The study focuses on evaluating hormones that affect vascular contractility and sodium balance. The major areas of focus are the renin angiotensin aldosterone system (RAAS), kallikrein, cortisol, adducin, the beta-2 adrenergic receptor and ion transport systems.
“We want to understand the genetic factors that contribute to a patient’s hypertension,” explained Dr. Fisher. “High blood pressure could be the result of having too many risk genes or not enough protective genes.” (For more information on HyperPATH, contact Dr. Williams at gwilliams@partners.org or 617-525-7288)
Dr. Fisher is also enrolling patients in the BP-Connect Program, an initiative designed to promote patients’ self-management of their hypertension.
“The program engages patients daily through a remote tele-monitoring platform, where they can record their blood pressure measurements and report symptoms. Their care providers can view the uploaded data, thereby ensuring continuum of care, even outside of hospital settings,” said Dr. Fisher.
The 230 enrolled participants were given a kit containing a blood pressure cuff and a device that transfers blood pressure data to a central database at BWH. Patients measure their blood pressures one to two times daily for three months and data are available electronically to both patients and providers.
The BP-Connect Program aims to lower blood pressure below <140 mm Hg systolic or <90 mm Hg diastolic over the three-month intervention period. The program began enrolling patients in early 2016 and will continue through 2017. (For more information on BP-Connect, contact Dr. Fisher at nfisher@partners.org or 617-732-5666)
Dr. Fisher is the clinical lead of the Brigham Protocol-based Hypertension Optimization Program (BP-HOP) pilot study, leading a collaborative team including primary care, cardiology, and nephrology. The study, which launches in January, aims to manage hypertension through a remote, algorithm-driven treatment plan.
The study will enroll up to 800 patients with uncontrolled hypertension, and will use patient coaches, navigators, and pharmacists to implement a comprehensive hypertension treatment algorithm, designed by experts in hypertensive management. Much of the contact with patients will be remote to allow more frequent and rapid cycling of blood pressure assessments and treatment changes. (For more information on this study, contact Dr. Fisher at nfisher@partners.org or 617-732-5666)
Our Physician Liaison Ellen Steward can provide direct assistance with patient referrals and consultations. Ellen can be reached at (617) 582-4733 or esteward@partners.org.
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