TARGET BP I Clinical Trial
- Conditions
- Hypertension
- Interventions
- Device: Peregrine System Kit (Sham Procedure)
- Registration Number
- NCT02910414
- Lead Sponsor
- Ablative Solutions, Inc.
- Brief Summary
The TARGET BP I Trial is a randomized, blinded, multi-center, international, sham-procedure controlled trial, comparing renal denervation performed with the Peregrine System Kit in the treatment group to the sham control group (without renal denervation - no alcohol infusion). Subjects will be randomized in a 1:1 fashion to treatment versus sham control via central randomization.
- Detailed Description
The TARGET BP I Trial is a randomized, blinded, multi-center, international, sham-procedure controlled trial, comparing renal denervation performed with the Peregrine System Kit in the treatment group to the sham control group (without renal denervation - no alcohol infusion). Subjects will be randomized in a 1:1 fashion to treatment versus sham control via central randomization.
The TARGET BP I clinical trial uses a percutaneous catheter to deliver very small amounts of alcohol (neurolytic agent). The patient population for this trial is comparable to those used in other renal denervation studies, but also incorporates lessons learned from recent trials of renal denervation. This is to enable the study of an optimized patient population who stands to benefit from the intervention, in a manner that reduces possible study bias.
This trial is intended to evaluate the safety and efficacy of the Peregrine Catheter when used to deliver a 0.6 mL volume of alcohol to the perivascular area of the respective renal arteries while patients are adequately managed with oral antihypertensive medications.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 300
- Has 3 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 when receiving 2 to 5 antihypertensive medications.
- Has a mean 24-hour ambulatory SBP of ≥135 mmHg and ≤170 mmHg with ≥70% valid readings
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Renal Angiography Only (Sham Procedure) Peregrine System Kit (Sham Procedure) The sham control group will only have diagnostic renal angiography performed. There will be no insertion of the Peregrine Catheter and no alcohol infusion (i.e. no renal denervation). Treated with Peregrine System Kit Dehydrated alcohol The experimental group will receive an infusion of Dehydrated Alcohol Injection, USP into the perivascular space of the renal arteries with the Peregrine Catheter. A total of 0.6mL of the alcohol will be delivered to the perivascular space of each renal artery. The drug will only be delivered once to each renal artery during the treatment procedure.
- Primary Outcome Measures
Name Time Method Change in mean systolic ABPM 3 months The change in mean 24-hour ambulatory SBP from baseline to 3 months post-procedure
- Secondary Outcome Measures
Name Time Method Proportion of subjects with major adverse events 30 days Major Adverse Events as defined in the clinical protocol
Office BP responders (10 mmHg) 3 months Office BP Responders, defined as the proportion of subjects with a drop of ≥10 mmHg in office SBP at 3 months compared with baseline.
Major Adverse Events 3, 6, and 12 months and 2 and 3 years Major Adverse Events as defined in the clinical protocol
Change of 24-hour mean systolic ABPM 6 months Change of 24-hour mean systolic ABPM from baseline to 6 months
Changes in antihypertensive regimen 3 months Changes in antihypertensive regimen from procedure to 3 months post-procedure
ABPM responders (5 mmHg) 3 months ABPM Responders, defined as the proportion of subjects with a drop of ≥5 mmHg in 24-hour ambulatory SBP at 3 months compared with baseline.
Decrease in eGFR > 25% 3 and 6 months Decrease in eGFR \> 25% at 3 and 6 months
Changes in eGFR 3 and 6 months Changes in eGFR at 3 and 6 months
Adverse event rate Procedure date, discharge date (an average of 1 day), 5-day, 4 weeks, 8 weeks, 3 months, 4 months, 5 months, 6 months, 1 year, 2 years and 3 years Adverse event rate at procedure, discharge, and at all follow-up visits
Change in mean office SBP 6 months Change in mean office SBP from baseline to 6 months post-procedure
Change in mean daytime ambulatory SBP 6 months Change in mean daytime ambulatory SBP from baseline to 6 months post procedure.
Change in mean daytime ambulatory DBP 3 and 6 months Change in mean daytime ambulatory DBP from baseline to 3 months and then 6 months post procedure.
Device success Procedure date (day 0) Device success, defined as successful introduction of the catheter, navigation to the treatment site, deployment of the needles, and infusion of the alcohol to the intended area via the Peregrine Catheter as intended for use
Procedure success Hospital discharge date (an average of 1 day) Procedure success defined as device success and freedom from serious adverse events related to the product or the procedure, during the procedure and prior to hospital discharge from the index procedure.
Change of office systolic blood pressure 8 weeks Change of office systolic blood pressure from baseline to 8 weeks
Change of diastolic office blood pressure 3 and 6 months Change of diastolic office blood pressure from baseline to 3 and 6 months
Change of 24-hour mean diastolic ABPM 3 and 6 months Change of 24-hour mean diastolic ABPM from baseline to 3 and 6 months
Changes (decreases or increases) in antihypertensive medication regimen from 3 months to 6 months post-procedure 3 and 6 months Changes (decreases or increases) in antihypertensive medication regimen from 3 months to 6 months post-procedure (titrated according to standardized formula to maintain a target office SBP of \< 140 mmHg and ≥ 90 mmHg).
Changes (decreases or increases) in antihypertensive medication regimen from procedure to 6 months post-procedure 6 months Changes (decreases or increases) in antihypertensive medication regimen from procedure to 6 months post-procedure (titrated according to standardized formula to maintain a target office SBP of \<140 mmHg and ≥90 mmHg)
Change in mean nighttime ambulatory SBP 3 and 6 months Change in mean nighttime ambulatory SBP from baseline to 3 months and then 6 months post procedure.
Change in mean nighttime ambulatory DBP 3 and 6 months Change in mean nighttime ambulatory DBP from baseline to 3 months and then 6 months post procedure.
Reduction of office SBP and DBP to normal 3, 6, and 12 months Reduction of office SBP and DBP to normal (\<140/90 mmHg) at 3, 6 and 12 months as compared to baseline.
Trial Locations
- Locations (5)
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Wake Forest University Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
NC Heart and Vascular Research
🇺🇸Raleigh, North Carolina, United States
Piedmont Heart Institute
🇺🇸Atlanta, Georgia, United States
Cardiology PC
🇺🇸Birmingham, Alabama, United States