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
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 202
- 试验地点
- 2
- 主要终点
- Changes in Systolic Ambulatory Blood Pressure at 8 weeks
研究概览
简要总结
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.
详细描述
This Phase 3, prospective, randomized, blinded, sham procedure-controlled, multicenter study will assess the efficacy and safety of renal denervation by alcohol-mediated neurolysis using the Peregrine Catheter in hypertensive subjects in the absence of antihypertensive medications. Subjects with a documented history of uncontrolled hypertension who are taking 0, 1, or 2 antihypertensive medications at enrollment will be recruited. After providing written informed consent, subjects will undergo screening assessments to assess eligibility for the study. Eligible subjects will then enter a run-in period during which they will take no antihypertensive medications. Subjects who continue to be eligible at the end of the run-in period will complete the study Baseline visit and remain without taking antihypertensive medications. Subjects who continue to be eligible after the completion of the Baseline visit will attend the study site and will be randomized to either the Treatment Arm (renal denervation using the Peregrine Catheter) or the Sham Control Arm (renal angiography only).
After study unblinding, crossover from the Sham Control Arm to the Treatment Arm may be allowed, at the discretion of the treating investigator.
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, Investigator, Outcomes Assessor)
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 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.
- •Documented history of uncontrolled hypertension and is currently taking 0, 1, or 2 antihypertensive medications.
- •Is willing to discontinue any current antihypertensive medications for at least 13 weeks (5-week pre-procedure and 8-week post-procedure).
- •Has a mean 24-hour ambulatory SBP of ≥140 mmHg and ≤170 mmHg with required valid readings.
排除标准
- •Has renal artery anatomy abnormalities.
- •Has previously undergone renal denervation.
- •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.
- •Has documented untreated sleep apnea.
- •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).
- •Is pregnant or lactating at the time of enrollment or planning to become pregnant during the trial time period (female subjects only).
- •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.
- •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
Treatment Arm
Renal denervation performed with dehydrated alcohol injection, USP administered via the Peregrine System™ Infusion Catheter.
干预措施: Dehydrated Alcohol Injection, USP (Drug)
Sham Control Arm
Only renal angiography performed
干预措施: Sham procedure (Procedure)
结局指标
主要结局
Changes in Systolic Ambulatory Blood Pressure at 8 weeks
时间窗: Baseline to 8 weeks post-treatment
Change from baseline in mean 24-hour ambulatory systolic blood pressure
次要结局
- Change in Office SBP at 8 Weeks(Baseline to 8 weeks post-treatment)
- Change in Office DBP at 8 Weeks(Baseline to 8 weeks post-treatment)
- Changes in Diastolic Ambulatory Blood Pressure at 8 Weeks(Baseline to 8 weeks post-treatment)
- Changes in Systolic Ambulatory Blood Pressure at 6 Months(Baseline to 6 months post-treatment)
- Changes in Diastolic Ambulatory Blood Pressure at 6 Months(Baseline to 6 months post-treatment)
- Changes in Mean Daytime Ambulatory SBP at 8 Weeks(Baseline to 8 weeks post-treatment)
- Changes in Mean Daytime Ambulatory SBP at 6 Months(Baseline to 6 months post-treatment)
- Changes in Mean Nighttime Ambulatory DBP at 6 Months(Baseline to 6 months post-treatment)
- Changes in Mean Daytime Ambulatory DBP at 8 Weeks(Baseline to 8 weeks post-treatment)
- Changes in Mean Daytime Ambulatory DBP at 6 Months(Baseline to 6 months post-treatment)
- Changes in Mean Nighttime Ambulatory SBP at 8 Weeks(Baseline to 8 weeks post-treatment)
- Changes in Mean Nighttime Ambulatory SBP at 6 Months(Baseline to 6 months post-treatment)
- Changes in Mean Nighttime Ambulatory DBP at 8 Weeks(Baseline to 8 weeks post-treatment)
- Change in Office DBP at 6 Months(Baseline to 6 months post-treatment)
- Use of Antihypertensive Medication(s) at 8 Weeks(8 weeks post-treatment)
- Use of antihypertensive medication(s) from 8 Weeks to 6 Months(6 months post-treatment)
- Number of Participants With Major Adverse Events (MAEs)(30 days post-treatment)
- Change in Office SBP at 6 Months(Baseline to 6 months post-treatment)
- Change in Home SBP at 8 Weeks(8 weeks post-treatment)
- Change in Home SBP at 6 months(6 months post-treatment)
- Change in Home DBP at 8 Weeks(8 weeks post-treatment)
- Change in Home DBP at 6 months(6 months post-treatment)