The TARGET BP OFF-MED Trial
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment Arm: Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter |
Drug: Alcohol
Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries
|
| Sham Comparator: Sham Control Arm Only renal angiography performed |
Other: Sham control
endovascular, renal angiography
|
Outcome Measures
Primary Outcome Measures
- Changes in Systolic Ambulatory Blood Pressure [Baseline to 8 weeks post-treatment]
Change in mean 24-hour ambulatory SBP
Secondary Outcome Measures
- Changes in Ambulatory Blood Pressure [Baseline, and 8 weeks, 6 months, 12 months post treatment]
Change in mean 24-hour, daytime, and nighttime ambulatory SBP and DBP
- Changes in Office Blood Pressure [Baseline, and 4 weeks, 8 weeks, 3 months, 6 months, 1 year and 2 years post treatment]
Change in mean office SBP and DBP
- Use of antihypertensive medication(s) [8 weeks, 6 months,1 year post treatment]
Evaluate differences between groups
- Evaluation of safety [30 days post procedure]
Major adverse events (MAEs)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
Exclusion Criteria:
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cliniques Universitaires Saint-Luc | Brussels | Belgium | 1200 | |
| 2 | Clinique Pasteur Toulouse | Toulouse | France | ||
| 3 | Universitätsklinikum des Saarlandes | Homburg/Saar | Germany | 66421 | |
| 4 | NIHR Barts Cardiovascular Biomedical Research Unit | London | United Kingdom | EC1M 6BQ |
Sponsors and Collaborators
- Ablative Solutions, Inc.
Investigators
- Principal Investigator: Felix Mahfoud, Prof.Dr.med., Universitätsklinikum des Saarlandes Klinik für Innere Medizin III Kardiologie, Angiologie und Internistische Intensivmedizin, Germany
- Principal Investigator: Atul Pathak, Prof., Clinique Pasteur Hi-LAB, Toulouse, France
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR0014