A Pivotal, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System™ Kit, in Subjects With Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 5
- 主要终点
- Change in mean systolic ABPM
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Treated with Peregrine System Kit
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.
干预措施: Dehydrated alcohol (Drug)
Renal Angiography Only (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).
干预措施: Peregrine System Kit (Sham Procedure) (Device)
结局指标
主要结局
Change in mean systolic ABPM
时间窗: 3 months
The change in mean 24-hour ambulatory SBP from baseline to 3 months post-procedure
次要结局
- Office BP responders (10 mmHg)(3 months)
- Major Adverse Events(3, 6, and 12 months and 2 and 3 years)
- Change of 24-hour mean systolic ABPM(6 months)
- Changes in antihypertensive regimen(3 months)
- ABPM responders (5 mmHg)(3 months)
- Proportion of subjects with major adverse events(30 days)
- Decrease in eGFR > 25%(3 and 6 months)
- Changes in eGFR(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)
- Change in mean office SBP(6 months)
- Change in mean daytime ambulatory SBP(6 months)
- Change in mean daytime ambulatory DBP(3 and 6 months)
- Device success(Procedure date (day 0))
- Procedure success(Hospital discharge date (an average of 1 day))
- Change of office systolic blood pressure(8 weeks)
- Change of diastolic office blood pressure(3 and 6 months)
- Change of 24-hour mean diastolic ABPM(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 procedure to 6 months post-procedure(6 months)
- Change in mean nighttime ambulatory SBP(3 and 6 months)
- Change in mean nighttime ambulatory DBP(3 and 6 months)
- Reduction of office SBP and DBP to normal(3, 6, and 12 months)