The TARGET BP I Trial

Condition: Hypertension

Eligibility

Key Inclusion Criteria:

  • 18-80 years old
  • Taking 2-5 antihypertensive medications at time of enrollment and is willing to adhere to a stable (no change) medication regimen during the 4-week run-in period and 3 months post-procedure
  • Meets high blood pressure criteria

Key Exclusion Criteria:

  • Severe untreated obstructive sleep apnea
  • Diagnosis of the following causes of hypertension: Cushing’s disease or
    Cushing’s syndrome, hyperaldosteronism, pheochromocytoma, thyroid and parathyroid abnormalities, or onset of hypertension prior to 18 years old
Study Name

A Pivotal, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System Kit in Subjects With Hypertension (IRB no. 00000047)

Summary

The purpose of this study is to evaluate the effectiveness of an investigational device/drug system called the Peregrine System Kit for the treatment of blood pressure. The study aims to determine whether individuals whose high blood pressure is not sufficiently improved by medicine and lifestyle changes may be able to use renal denervation to reduce their high blood pressure, when used along with their current blood pressure medication.

The Peregrine Kit is designed to deliver small amounts of nerve-destroying medicine (alcohol) to the space around the kidney blood vessels (renal arteries). Destroying nerve fibers that run along the kidney blood vessels interrupts nerve signals that may cause high blood pressure. This is called renal denervation.

Participants will be randomly assigned to 1 of 2 study groups. The Treatment Group will undergo the experimental procedure to receive renal denervation with the Peregrine Kit. The Control Group will not receive renal denervation with the Peregrine Kit.

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