The TARGET BP OFF-MED Trial

Study Overview
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Brief Summary
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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
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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

Conditions
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Hypertension, Hypertension,Essential

Intervention / Treatment
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* Drug: Alcohol
* Other: Sham control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects who continue to be eligible at the end of the run-in period will be randomized in a 1:1 ratio to one of the following 2 groups via central randomization (stratified by study site): Treatment Arm: renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter Sham Control Arm: only renal angiography performed
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm:<br>Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter | Drug: Alcohol<br>* Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries<br>|
| Sham Comparator: Sham Control Arm<br>Only renal angiography performed | Other: Sham control<br>* endovascular, renal angiography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Systolic Ambulatory Blood Pressure | Change in mean 24-hour ambulatory SBP | Baseline to 8 weeks post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Ambulatory Blood Pressure | Change in mean 24-hour, daytime, and nighttime ambulatory SBP and DBP | Baseline, and 8 weeks, 6 months, 12 months post treatment | 
| Changes in Office Blood Pressure | Change in mean office SBP and DBP | Baseline, and 4 weeks, 8 weeks, 3 months, 6 months, 1 year and 2 years post treatment | 
| Use of antihypertensive medication(s) | Evaluate differences between groups | 8 weeks, 6 months,1 year post treatment | 
| Evaluation of safety | Major adverse events (MAEs) | 30 days post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal Denervation, Neurolysis