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HIGH BLOOD PRESSURE?

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See if you qualify for the TARGET BP I Clinical Trial

 

An investigational product used in a minimally invasive procedure to help reduce blood pressure is now being studied. Patients with high blood pressure that is not well controlled despite taking anti-hypertensive medications might qualify to participate in the TARGET BP I Clinical Trial.

The TARGET BP I Clinical Trial is evaluating the investigational Peregrine System Kit which is used in a minimally invasive procedure with the goal of reducing blood pressure by deactivating specific nerves surrounding the renal (kidney) arteries that, through over-signaling, can contribute to high blood pressure. Patients will continue taking anti-hypertensive medications during the trial.


The 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 is designed to deliver a small dose of Ablative Solutions medical alcohol to the region just outside the artery, where these sympathetic nerves are located, to deactivate their over-signaling.

 

Participation in the TARGET BP I Clinical Trial could help clinicians understand the potential role of a

procedure that is designed to help reduce blood pressure. The results of the research may help with the treatment of this condition. If interested in learning more, follow the “Do I Qualify?” link.

 

What is high blood pressure?

High blood pressure (a value equal to or greater than 130/80 mmHg (8)) 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, reduced kidney function, 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 I Clinical Trial?

The purpose of the trial is to investigate the safety and efficacy of the investigational Peregrine System™ Kit in the treatment of patients with uncontrolled hypertension who are taking 2-5 anti-hypertensive medications.

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 three years after the procedure.

What is the Peregrine System Kit?

The Peregrine Kit includes the Peregrine Catheter and Ablative Solutions medical alcohol. The Peregrine System Kit is used during a minimally invasive procedure that is 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 Ablative Solutions medical 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 I Clinical Trial is randomized between a treatment arm and a control arm - which means that some patients will receive the investigational Peregrine Kit, while patients in the control arm will receive a diagnostic procedure, but no treatment with the Peregrine Kit. 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?

The Peregrine Kit is currently being studied in another trial in Europe, the TARGET BP OFF-MED Clinical Trial, which will involve 90 patients. Results from another European study of the CE-marked Peregrine Catheter, which is part of the investigational Peregrine Kit, were presented in March 2019.

Additional Information:

Patients may be eligible for the TARGET BP I Clinical Trial if: 

  • between the ages of 18 and 80

  • taking 2-5 antihypertensive medications

  • with an average blood pressure equal to or greater than 150 mmHg systolic / 90 mmHg diastolic

To learn more about the trial and answer trial eligibility screening questions, please click on the link below. If you prefer to take the quiz over the phone, you can call 1-888-993-0663.

 

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) Whelton et al, 2017 ACC/AHA /AAPA/ABC /ACPM/AGS/APhA/ ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults, Journal of the American College of Cardiology May 2018, 71 (19) e127-e248; DOI: 10.1016/j.jacc.2017.11.006

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)