What is high blood pressure?
High blood pressure (a value equal to or greater than 140/90 mmHg(8,9)) is a common condition in which the force of the blood flowing through the arteries is too high. High blood pressure causes the heart to work much harder while pumping blood throughout the body, putting strain on arteries, which can eventually lead to other health problems such as heart attack, stroke, and loss of vision.
The sympathetic nerve system plays an important role in maintaining the body’s balance –
including regulating healthy blood pressure – sending messages between the brain and organs. If, however, the nerves are overactive and send too many signals, this can contribute to high blood pressure. Physicians have demonstrated that interrupting nerve pathways contributing to overactive signaling can help in reducing blood pressure.(10,11)
What is the purpose of the TARGET BP OFF-MED Clinical Trial?
The purpose of the trial is to investigate the effectiveness of the Peregrine Procedure in treating high blood pressure. Participants will include patients who do not take antihypertensive medication and those on 1-2 antihypertensive medications who will stop taking these medications for 3 months during the trial, in order to clearly evaluate the benefit of the procedure alone in managing high blood pressure.
How long does the trial last?
Patients will be asked to make office visits to be seen by study investigators both before and after the procedure, in order to monitor the effects of the treatment on blood pressure over time. The procedure itself should require no more than one overnight stay. The last follow-up visit for the trial will take place two years after the procedure.
What is the Peregrine Procedure?
The Peregrine Procedure is a minimally invasive procedure that will be performed under mild sedation. The Peregrine Catheter will be inserted through a small incision in the groin and guided up to the renal (kidney) arteries using angiography (like an X-ray). The system will deliver a small dose of dehydrated alcohol to the region just outside the artery where the sympathetic nerves are located, to deactivate the over-signaling of these nerves.
Why is the trial randomized?
The TARGET BP OFF-MED Clinical Trial is randomized between a treatment arm and a control arm - which means that some patients will receive the Peregrine Procedure, while patients in the control arm will receive a diagnostic procedure, but no treatment with the Peregrine Procedure. All patients will be actively monitored and managed by the study investigators. Patients will not know which study arm they are in. The reason for this trial design is that it could help to clarify how effectively the procedure reduces blood pressure as compared to other factors, such as the benefits of active blood-pressure monitoring as a participant in the trial.
Has the Peregrine Procedure been studied before? Where can I find the data?
In addition to the TARGET BP OFF-MED Clinical Trial, the Peregrine System Infusion Catheter has been studied in a post-market evaluation(12,13) in select regions in Europe regulated by the CE Mark as well as in a first-in-human study.(14)
Patients may be eligible for the TARGET BP OFF-MED Clinical Trial if:
between the ages of 18 and 80
with an average blood pressure equal to or greater than 140 mmHg systolic / 90 mmHg diastolic
To learn more about the trial and answer trial eligibility screening questions, please click on the link below.