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TARGET BP I Clinical Trial
Recruiting
Trial ID: NCT02910414
Purpose
The TARGET BP I Trial is a randomized, blinded, multi-center, international, sham-procedure
controlled trial, comparing renal denervation performed with the Peregrine System Kit in the
treatment group to the sham control group (without renal denervation - no alcohol infusion).
Subjects will be randomized in a 1:1 fashion to treatment versus sham control via central
randomization.
Official Title
A Pivotal, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System™ Kit, in Subjects With Hypertension
Stanford Investigator(s)
Eligibility
Inclusion Criteria:
1. 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.
2. Has a mean 24-hour ambulatory SBP of ≥135 mmHg and ≤170 mmHg with ≥70% valid readings
Exclusion Criteria:
1. Subject has renal artery anatomy abnormalities.
2. Subject has an estimated glomerular filtration rate (eGFR) of ≤45 mL/min/1.73 m2,
based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation; or
is on chronic renal replacement therapy.
3. Subject has documented sleep apnea.
4. Subject has any of the following conditions: severe cardiac valve stenosis, heart
failure (New York Heart Association [NYHA] Class III or IV), chronic atrial
fibrillation, and known primary pulmonary hypertension (>60 mmHg pulmonary artery or
right ventricular systolic pressure).
5. Subject is pregnant or lactating at the time of enrollment or planning to become
pregnant during the trial time period (female subjects only).
6. Subject is being treated chronically (e.g. daily use) with NSAIDs, immunosuppressive
medications, or immunosuppressive doses of steroids. Aspirin therapy and nasal
pulmonary inhalants are allowed.
7. Subject has a history of myocardial infarction, unstable angina pectoris, or
stroke/TIA within 6 months prior to the planned procedure.
Intervention(s):
drug: Dehydrated alcohol
device: Peregrine System Kit (Sham Procedure)
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305