NCT03503773CompletedPhase 2
The TARGET BP OFF-MED Trial
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
Source: ClinicalTrials.gov · Last updated 14 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 350 (actual)
- First submitted
- 23 Mar 2018
- Start date
- 24 Sept 2018
- Primary completion date
- 31 Jan 2022
- Lead sponsor
- Ablative Solutions, Inc.
- Diseases
- High blood pressure
- NCT number
- NCT03503773
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 350
- From 24 Sept 2018 to the primary completion date, 31 Jan 2022
- 4 sites in 4 countries
- 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 ≥140 mmHg and ≤180 mmHg, AND a mean office diastolic blood pressure (DBP) of ≥90 mmHg.
- Subject is willing to discontinue any current antihypertensive medications during the run-in period and the post-treatment period.
- 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 (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cliniques universitaires Saint-Luc Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| Universitätsklinikum des Saarlandes Coordinator of this site? Confirm its status | Homburg/Saar | Germany | Unknown status |
| Clinique Pasteur - Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| NIHR Barts Cardiovascular Biomedical Research Unit Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.