<Orange, CA>—Providence St. Joseph Hospital Heart and Vascular Center enrolled and randomized the first patient in Orange County, California, in the TARGET BP I global trial. The clinical trial is evaluating a new, investigational treatment for patients with hypertension (high blood pressure). The treatment is designed to deactivate specific nerves around the arteries of the kidneys.
“This new investigational technique for treating high blood pressure utilizing the Peregrine System KitTM is minimally invasive and is carried out under mild sedation,” according to Mahmood Razavi, MD, Director of Interventional Clinical Trials at Providence St. Joseph and the principal investigator leading the study. The doctor uses a special catheter that is inserted through a small incision in the groin and guided to the renal arteries using angiography. “The catheter delivers a small dose of medical alcohol to the area just outside the renal artery where the nerves that contribute to the increase in blood pressure are located,” said Razavi. “The alcohol has the effect of deactivating the over-signalling of the nerves and this in turn reduces the blood pressure.”
As many as one in three adults have high blood pressure worldwide. High blood pressure, if untreated, can lead to stroke, heart failure, kidney disease among many other complications. According to Maged Azer, MD, Medical Director of Heart Failure at Providence St. Joseph Hospital, “The standard treatment for high blood pressure includes diet, exercise and prescription medication which can be very effective; however, there are some patients who are still unable to manage their blood pressure with these interventions alone and this clinical trial is an important step towards delivering an alternative treatment.”
The Peregrine System Kit has been studied in the Post-Market Study, a European multicenter open-label trial that evaluated additional safety and performance of the Peregrine System Infusion Catheter using a neurolytic agent (dehydrated alcohol) delivered into the space outside of the renal (kidney) arteries in 45 patients with systemic hypertension. Patients included in the study were taking at least three anti-hypertensive medications. At six months, mean 24-h ambulatory SBP was reduced by 11 mm Hg, and diastolic blood pressure was reduced by 7 mm Hg. Medication adherence was monitored and remained stable throughout the study. The primary safety endpoint, defined as absence of periprocedural major vascular complications, major bleeding, acute kidney injury, or death within one month, was met in 96% of patients (95% CI: 85% to 99%).
For further information or interest in participating in this study, please contact the Providence St. Joseph Principal Clinical Research Coordinator at 714-744-8795 or email sandy.chung@stjoe.org.
The clinical trial for this new treatment for high blood pressure is underway in 80 hospitals in the United States and Europe and further information can be found at www.targetbp1.com and www.clinicaltrials.gov.
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CAUTION: The Peregrine System Kit is an investigational product that is currently being studied to evaluate safety and effectiveness when used in the treatment of patients with uncontrolled hypertension and is limited to investigation use in clinical trials
