Renal Artery Denervation Assessment Without Antihypertensive Medication Regimen (RADAR)

Launched by ABLATIVE SOLUTIONS, INC. · Jul 17, 2025

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ClinConnect Summary

This clinical trial, called RADAR, is studying a new way to treat high blood pressure (hypertension) without using daily blood pressure medicines. The treatment involves a procedure where a small amount of dehydrated alcohol is injected into the nerves around the kidneys using a special catheter. This is done to help lower blood pressure by calming the nerves that can cause it to stay high. The study aims to find out how safe and effective this treatment is for people with high blood pressure who stop taking their usual blood pressure medications during the trial.

People who might be eligible for this study are adults with high blood pressure that is not well controlled, even though they are taking one or two blood pressure medicines. To join, participants must have certain blood pressure readings showing their pressure is still high, and they need to agree to stop taking blood pressure medicines for about 13 weeks—5 weeks before and 8 weeks after the procedure. The study is not open yet and will include both men and women between the ages of 18 and 74. Some people won’t be able to join, such as those with kidney problems, certain heart conditions, or who are pregnant. If you join, you can expect to have the procedure done and be closely monitored to see how your blood pressure responds without medications. This trial offers a new approach that might help people manage high blood pressure in a different way than pills.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Has 2 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.
• • 2. Documented history of uncontrolled hypertension and is currently taking 1 or 2 antihypertensive medications.
• • 3. Is willing to discontinue any current antihypertensive medications for at least 13 weeks (5-week pre-procedure and 8-week post-procedure).
• • 4. Has a mean 24-hour ambulatory SBP of ≥140 mmHg and ≤170 mmHg with required valid readings.
• Exclusion Criteria:
• • 1. Has renal artery anatomy abnormalities.
• • 2. Has previously undergone renal denervation.
• • 3. 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.
• • 4. Has documented untreated sleep apnea.
• • 5. Has any of the following conditions: severe cardiac valve stenosis, heart failure (New York Heart Association \[NYHA\] Class III or IV), chronic atrial fibrillation (defined as at least one documented episode in the 12 months before study entry), and known primary pulmonary hypertension (\>60 mmHg pulmonary artery or right ventricular systolic pressure).
• • 6. Is pregnant or lactating at the time of enrollment or planning to become pregnant during the trial time period (female subjects only).
• • 7. 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.
• • 8. Has a history of myocardial infarction, unstable angina pectoris, or stroke/TIA within 6 months prior to the planned procedure.