Hypertension
Conditions
Keywords
Renal Denervation, Alcohol
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.
Interventions
Dehydrated Alcohol Injection, USP is used in the study.
DEVICEPeregrine System Kit (Sham Procedure)
Pre-procedural diagnostic renal angiography only, performed for confirmation of anatomical eligibility prior to randomization
Sponsors
Ablative Solutions, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 2. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in mean systolic ABPM | 3 months | The change in mean 24-hour ambulatory SBP from baseline to 3 months post-procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major Adverse Events | 3, 6, and 12 months and 2 and 3 years | Major Adverse Events as defined in the clinical protocol |
| 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 |
| 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 |
| Change of 24-hour mean systolic ABPM | 6 months | Change of 24-hour mean systolic ABPM from baseline to 6 months |
| Proportion of subjects with major adverse events | 30 days | Major Adverse Events as defined in the clinical protocol |
| 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. |
| 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. |
| 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 | 3 months | Change in mean daytime ambulatory SBP from baseline to 3 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. |
| 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. |
| Changes in antihypertensive regimen | 3 months | Changes in antihypertensive regimen from procedure to 3 months post-procedure |
Countries
United States
Outcome results
None listed