Renal Artery Denervation Assessment Without Antihypertensive Medication Regimen (RADAR)
A Prospective Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation Using the Dehydrated Alcohol Injection, USP Administered With the Peregrine System™ Infusion Catheter in Subjects With Hypertension, in the Absence of Antihypertensive Medications
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 80 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how safe and effective an alcohol injection near nerves around the kidney arteries is for lowering blood pressure. The injection uses the Peregrine System catheter, a thin tube. It is for people with uncontrolled high blood pressure who will not take blood pressure medicine during the study period.
To obtain an assessment of the efficacy and safety of renal denervation by dehydrated alcohol injection, USP administered via the Peregrine System™ Infusion Catheter in hypertensive subjects in the absence of antihypertensive medications.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Two office blood pressure checks average 150–180 mmHg for the top number and at least 90 mmHg for the bottom number.
- Have a recorded history of uncontrolled high blood pressure and currently take 0, 1, or 2 blood pressure medicines.
- Agree to stop blood pressure medicines for at least 13 weeks: 5 weeks before the procedure and 8 weeks after.
- A blood pressure monitor worn for 24 hours shows an average top number of 140–170 mmHg, with the required usable readings.
Who can't join
- Have an abnormal shape or structure of the kidney arteries.
- Have already had renal denervation, a procedure that treats nerves around the kidney arteries.
- Have an estimated kidney filtering rate (eGFR) of 45 mL/min/1.73 m² or lower, or receive ongoing treatment to replace kidney function.
- Have documented, untreated sleep apnea, a condition that causes breathing to stop and start during sleep.
- Have severely narrowed heart valves; severe heart failure (NYHA class III or IV); chronic atrial fibrillation, an irregular heartbeat recorded at least once in the past 12 months; or known primary pulmonary hypertension, with pressure above 60 mmHg in the lung artery or right lower heart chamber.
- Are pregnant or breastfeeding when joining, or plan to become pregnant during the study.
- Regularly take NSAIDs (anti-inflammatory pain medicines), medicines that weaken the immune system, or steroid doses that weaken the immune system. Aspirin and inhaled medicines for the nose or lungs are allowed.
- Had a heart attack, unstable angina (chest pain), stroke, or TIA (mini-stroke) within 6 months before the planned procedure.
Simplified for readability. The official criteria below are what the study team uses.
Official 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 0, 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.
Study sites (1)
TN
- Tennova Turkey Creek Medical Center · Knoxville, TN 37934More trials in Knoxville