The TARGET BP OFF-MED Trial

Ablative Solutions, Inc.350 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

350

Conditions

Hypertension Hypertension,Essential

Interventions

AlcoholDRUG

Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries

Sham controlOTHER

endovascular, renal angiography

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 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. 2. Subject is willing to discontinue any current antihypertensive medications during the run-in period and the post-treatment period. 3. Has a mean 24-hour ambulatory SBP of ≥135 mmHg and ≤170 mmHg with ≥70% valid readings Exclusion Criteria: 1. Subject has renal artery anatomy abnormalities. 2. 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. 3. Subject has documented sleep apnea. 4. 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). 5. Subject is pregnant or lactating at the time of enrollment or planning to become pregnant during the trial time period (female subjects only). 6. 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. 7. Subject has a history of myocardial infarction, unstable angina pectoris, or stroke/TIA within 6 months prior to the planned procedure.

Locations (4)

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Clinique Pasteur Toulouse

Toulouse, France

Universitätsklinikum des Saarlandes

Homburg/Saar, Germany

NIHR Barts Cardiovascular Biomedical Research Unit

London, United Kingdom

Outcomes

Primary Outcomes

Changes in Systolic Ambulatory Blood Pressure

Change from baseline in mean 24-hour ambulatory systolic blood pressure

Time frame: Baseline to 8 weeks post-treatment

Secondary Outcomes

Change in Mean 24-Hour Ambulatory Systolic Blood Pressure at 6 Months

Change from baseline in mean 24-hour ambulatory systolic blood pressure from baseline to 6 months

Time frame: 6 months

Change in Mean 24-Hour Ambulatory Systolic Blood Pressure at 12 Months

Change from baseline in mean 24-hour systolic blood pressure at 12 months post-procedure

Time frame: 12 months

Change in Office SBP at 8 Weeks

Change from Baseline in mean office SBP to Week 8

Time frame: 8 weeks

Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 8 Weeks

Change from baseline in mean 24-hour ambulatory diastolic blood pressure and 8 weeks post-procedure

Time frame: 8 weeks

Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 6 Months

Change from baseline in mean 24-hour ambulatory diastolic blood pressure at 6 months post-procedure

Time frame: 6 months

Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 12 Months

Change from baseline in mean 24-hour diastolic blood pressure 12 months post-procedure

Time frame: 12 months

Number of Participants With Major Adverse Events (MAEs)

Data from ClinicalTrials.gov

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Number of participants with major adverse events (MAEs) 30 days post-procedure

Time frame: 30 days post procedure

Use of Antihypertensive Medication(s)

Use of antihypertensive medication at 8 weeks

Time frame: 8 weeks

Change in Mean Daytime Ambulatory Systolic Blood Pressure at 8 Weeks

Change from Baseline in Mean Daytime Ambulatory Systolic Blood Pressure to 8 Weeks

Time frame: 8 weeks

Change in Mean Daytime Ambulatory Systolic Blood Pressure at 6 Months

Change from Baseline in Mean Daytime Ambulatory Systolic Blood Pressure to 6 Months

Time frame: 6 months

Change in Mean Daytime Ambulatory Systolic Blood Pressure at 12 Months

Change from Baseline in Mean Daytime Ambulatory Systolic Blood Pressure to 12 Months

Time frame: 12 months

Mean Daytime Ambulatory Diastolic Blood Pressure

Change from Baseline in Mean Daytime Ambulatory Diastolic Blood Pressure to 8 Weeks

Time frame: 8 weeks

Change in Mean Daytime Ambulatory Diastolic Blood Pressure at 6 Months

Change from Baseline in Mean Daytime Ambulatory Diastolic Blood Pressure to 6 months

Time frame: 6 months

Change in Mean Daytime Ambulatory Diastolic Blood Pressure at 12 Months

Change from Baseline in Mean Daytime Ambulatory Diastolic Blood Pressure to 12 Months

Time frame: 12 months

Change in Mean Nighttime Ambulatory Systolic Blood Pressure at 8 Weeks

Change from Baseline in Mean Nighttime Ambulatory Systolic Blood Pressure to 8 Weeks

Time frame: 8 weeks

Change in Mean Nighttime Ambulatory Systolic Blood Pressure at 6 Months

Change from Baseline in Mean Nighttime Ambulatory Systolic Blood Pressure to 6 Months

Time frame: 6 months

Change in Mean Nighttime Ambulatory Systolic Blood Pressure to 12 Months

Change from Baseline in Mean Nighttime Ambulatory Systolic Blood Pressure to 12 Months

Time frame: 12 months

Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 8 Weeks

Change from Baseline in Mean Nighttime Ambulatory Diastolic Blood Pressure to 8 weeks

Time frame: 8 weeks

Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 6 Months

Change from Baseline in Mean Nighttime Ambulatory Diastolic Blood Pressure to 6 Months

Time frame: 6 months

Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 12 Months

Change from Baseline in Mean Nighttime Ambulatory Diastolic Blood Pressure to 12 Months

Time frame: 12 months

Change in Mean Office SBP at 6 Months

Change from Baseline in mean office SBP to 6 Months

Time frame: 6 months

Change in Mean Office SBP to 12 Months

Change from Baseline in mean office SBP to 12 Months

Time frame: 12 months

Change in Mean Office DBP to 8 Weeks

Change from Baseline in mean office DBP to 8 Weeks

Time frame: 8 weeks

Change in Mean Office DBP to 6 Months

Change from Baseline in mean office DBP to 6 Months

Time frame: 6 months

Change in Mean Office DBP at 12 Months

Change from Baseline in mean office DBP to 12 Months

Time frame: 12 months