LIVING WITH HIGH BLOOD PRESSURE? YOU'RE NOT ALONE.

See if you qualify for the TARGET BP OFF-MED Clinical Trial

High blood pressure affects nearly one in three adults worldwide.(1,2) If left untreated, it can result in stroke, heart attack, kidney disease, sexual dysfunction and vision loss.(3)

 

Standard interventions in treating high blood pressure such as diet, exercise, and prescription medications can be effective for some people. However, even with these therapies in place, some individuals might not be able to effectively manage their blood pressure.(4,5)


A minimally invasive new treatment to help reduce blood pressure is now being studied. Patients with high blood pressure who are otherwise healthy might qualify to participate in the TARGET BP OFF-MED Clinical Trial.

About the Trial

The TARGET BP OFF-MED Clinical Trial is evaluating the Peregrine Procedure, a minimally invasive intervention that has been shown in early studies(6,7) to reduce blood pressure by deactivating specific nerves surrounding the renal (kidney) arteries that, through over-signaling, can contribute to high blood pressure.   

 

The Peregrine Procedure is performed under mild sedation. The Peregrine Catheter will be advanced through a small incision in the groin and guided up to the renal 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 these sympathetic nerves are located, to deactivate their over-signaling. 

Why Enroll?

Participation in the TARGET BP OFF-MED Clinical Trial could help clinicians understand the potential benefits of an innovative therapy that may help reduce blood pressure. The results of the research may help with the treatment of this condition. If interested in learning more, follow the “Learn More About Trial Participation” link.

FAQs

What is high blood pressure?

High blood pressure (a value equal to or greater than 140 mmHg systolic / 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)

Additional Information:

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.

1) Bloch, Michael J, Worldwide prevalence of hypertension exceeds 1.3 billion, Journal of the American Society of Hypertension 10(10) (2016) 753-754.

2) World Health Organization,  Q&A on Hypertension, Updated Sept. 2015  (information accessed 29Mar2018)  (www.who.int/features/qa/82/en/)

3) World Health Organization,  Q&A on Hypertension, Updated Sept. 2015  (information accessed 29Mar2018)  (www.who.int/features/qa/82/en/)

4) Lobo, Sobotka and Pathak, Clinical Update – Interventional procedures and future drug therapy for hypertension, European Heart Journal (2017) 38,1101-1111.

5) Mahfoud et al, Proceedings from the 2nd European Clinical Consensus Conference for device-based therapies for hypertension: state of the art and considerations for the future, European Heart Journal (2017) 38, 3272-3281

6) Fischell et al, Transcatheter Alcohol-Mediated Perivascular Renal Denervation with the Peregrine System: First-in-Human Experience, J Am Coll Cardiol Intv 2016; 9:589-98   (March 28,  2016)

7) Bertog et al, CRT-200.21 Alcohol-mediated Renal Denervation to Treat Hypertension – The Peregrine Post-market Study, J Am Coll Cardiol Intv 2018; 11: S32-S33.  (26 Feb 2018).

8) Mancia et al, 2013 ESH/ESC Guidelines for the management of arterial hypertension, Journal of Hypertension 2013, 31:1281–1357

9) Mahfoud et al, Proceedings from the 2nd European Clinical Consensus Conference for device-based therapies for hypertension: state of the art and considerations for the future, European Heart Journal (2017) 38, 3272-3281

10) Lobo, Sobotka and Pathak, Clinical Update – Interventional procedures and future drug therapy for hypertension, European Heart Journal (2017) 38,1101-1111.

11) Mahfoud et al, Proceedings from the 2nd European Clinical Consensus Conference for device-based therapies for hypertension: state of the art and considerations for the future, European Heart Journal (2017) 38, 3272-3281

12) Bertog et al, CRT-200.21 Alcohol-mediated Renal Denervation to Treat Hypertension – The Peregrine Post-market Study, J Am Coll Cardiol Intv 2018; 11: S32-S33.  (26 Feb 2018).

13) Mahfoud, Felix, Chemical Renal Denervation with Ethanol – Update for a Promising Technology, Presentation at CRT March 2018.(www.crtonline.org/crt-premium) 

14) Fischell et al, Transcatheter Alcohol-Mediated Perivascular Renal Denervation with the Peregrine System: First-in-Human Experience, J Am Coll Cardiol Intv 2016; 9:589-98   (March 28,  2016)