The TARGET BP I Trial

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.


Inclusion Criteria

  • Has 3 office blood pressure measurements with a mean office systolic blood pressure (SBP) of ≥150 mmHg and ≤180 mmHg, AND a mean office diastolic blood pressure (DBP) of ≥90 mmHg when receiving 2 to 5 antihypertensive medications.
  • Has a mean 24-hour ambulatory SBP of ≥135 mmHg and ≤170 mmHg with ≥70% valid readings
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Study Location(s)

Beverly

More about this Clinical Trial

Full Title

A Pivotal, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System™ Kit, in Subjects with Hypertension

Details
Disease Type/Condition

Hypertension

Principal Investigator

Rader, Florian

Co-Investigators

Suhail Dohad

Age Group

Adult

Phase

III

IRB Number

STUDY00000047

ClinicalTrials.gov ID

NCT02910414

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?

Details
Disease Type/Condition

Hypertension

Principal Investigator

Rader, Florian

Age Group

Adult

Phase

III

IRB Number

CR0002

ClinicalTrials.gov ID

NCT02910414

Key Eligibility
ClinicalTrials.gov

Contact
Phone
310-423-6252
Email
clinicaltrials@cshs.org
Want to join the study or
learn more?