TARGET BP I Clinical Trial
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Hypertension
In brief
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.
Key facts
- Study ID
- NCT02910414
- Run by
- Ablative Solutions, Inc.
- People needed
- 300
- Starts
- 2019-07-22
- Expected to finish
- 2026-05-01
- Last updated by the study team
- 2023-10-03
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Subject has renal artery anatomy abnormalities.
- 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.
- Subject has documented sleep apnea.
- 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).
- Subject is pregnant or lactating at the time of enrollment or planning to become pregnant during the trial time period (female subjects only).
- 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.
- Subject has a history of myocardial infarction, unstable angina pectoris, or stroke/TIA within 6 months prior to the planned procedure.
Where it is running
- Cardiology PC — Birmingham, Alabama, United States
- Piedmont Heart Institute — Atlanta, Georgia, United States
- NC Heart and Vascular Research — Raleigh, North Carolina, United States
- Wake Forest University Baptist Medical Center — Winston-Salem, North Carolina, United States
- UT Southwestern Medical Center — Dallas, Texas, United States
Full record on ClinicalTrials.gov
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