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The TARGET BP OFF-MED Trial
Recruiting
Trial ID: NCT03503773
Purpose
To obtain an assessment of the efficacy and safety of renal denervation by alcohol-mediated
neurolysis using the Peregrine Kit in hypertensive subjects in the absence of
antihypertensive medications.
Official Title
A Phase 2, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System Kit, in Subjects With Hypertension, in the Absence of Antihypertensive Medications
Stanford Investigator(s)
Eligibility
Inclusion Criteria:
1. Has 3 office blood pressure measurements with a mean office systolic blood pressure
(SBP) of ≥140 mmHg and ≤180 mmHg, AND a mean office diastolic blood pressure (DBP) of
≥90 mmHg.
2. Subject is willing to discontinue any current antihypertensive medications during the
run-in period and the post-treatment period.
3. 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: Alcohol
other: Sham control
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305