NCT02910414Active, not recruitingPhase 3
TARGET BP I Clinical Trial
A Pivotal, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System™ Kit, in Subjects With Hypertension
Source: ClinicalTrials.gov · Last updated 3 Oct 2023
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 300 (actual)
- First submitted
- 16 Sept 2016
- Start date
- 22 Jul 2019
- Primary completion date
- Dec 2023
- Lead sponsor
- Ablative Solutions, Inc.
- Diseases
- High blood pressure
- NCT number
- NCT02910414
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 300
- From 22 Jul 2019 to the primary completion date, Dec 2023
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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).
Lab values
- 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.
Other
- Subject has renal artery anatomy abnormalities.
- Subject has documented sleep apnea.
- Subject is pregnant or lactating at the time of enrollment or planning to become pregnant during the trial time period (female subjects only).
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Piedmont Heart Institute Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Cardiology, PC Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| UT Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| NC Heart and Vascular Research Coordinator of this site? Confirm its status | Raleigh | United States | Unknown status |
| Wake Forest University Baptist Medical Center Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.