Department of Internal Medicine III, Cardiology, Angiology, Intensive Care Medicine, Saarland University Medical Center, Homburg, Germany.
State University of New York (SUNY), NY.
Am Heart J. 2021 Sep;239:90-99. doi: 10.1016/j.ahj.2021.05.015. Epub 2021 May 27.
Arterial hypertension is a common and life-threatening condition and poses a large global health burden. Device-based treatments have been developed as adjunctive or alternative therapy, to be used with or without antihypertensive medication for treating uncontrolled hypertension. The safety and feasibility of chemical renal denervation (RDN) using the Peregrine Catheter and alcohol were demonstrated in a first-in-man and open-label clinical trials, prompting the initiation of the ongoing TARGET BP OFF-MED and TARGET BP I trials.
The TARGET BP trials are randomized, blinded, sham-controlled trials designed to assess the safety and efficacy of alcohol-mediated RDN for the treatment of uncontrolled hypertension in the absence of antihypertensive medications (TARGET BP OFF-MED) or in addition to prescribed antihypertensive medications (TARGET BP I). Subjects with confirmed uncontrolled hypertension and suitable renal artery anatomy are randomized (1:1) to receive either RDN using the Peregrine Kit with alcohol (0.6 mL per renal artery) infused through the Peregrine Catheter or diagnostic renal angiography only (sham procedure). TARGET BP OFF-MED completed enrollment and randomized 96 subjects. TARGET BP I will randomize approximately 300 subjects and will transition to an open-label safety cohort of approximately 300 subjects receiving RDN once the primary efficacy endpoint of the Randomized Controlled Trial (RCT) cohort has been met. Primary endpoints are change in mean 24-hour ambulatory systolic blood pressure from baseline to 8 weeks (TARGET BP OFF-MED) and 3 months (TARGET BP I) post-procedure.
The TARGET BP trials are the first large-scale, international, randomized trials aimed to investigate the safety and BP lowering efficacy of a novel RDN method, with perivascular alcohol delivery using the Peregrine Kit.
动脉高血压是一种常见的、危及生命的疾病，给全球健康带来了沉重负担。已开发出基于器械的治疗方法，作为辅助或替代疗法，与降压药物联合或不联合用于治疗未控制的高血压。使用 Peregrine 导管和酒精进行化学肾去神经（RDN）的安全性和可行性已在首次人体和开放标签临床试验中得到证实，这促使正在进行的 TARGET BP OFF-MED 和 TARGET BP I 试验启动。
TARGET BP 试验是随机、双盲、假对照试验，旨在评估酒精介导的 RDN 治疗无降压药物（TARGET BP OFF-MED）或联合降压药物（TARGET BP I）治疗未控制高血压的安全性和疗效。确认患有未控制高血压且适合肾动脉解剖结构的患者被随机（1:1）分配接受 Peregrine 套件中的 RDN 治疗，酒精（每根肾动脉 0.6 毫升）通过 Peregrine 导管输注，或仅接受诊断性肾血管造影（假手术）。TARGET BP OFF-MED 完成了入组并随机分配了 96 名患者。TARGET BP I 将随机分配约 300 名患者，一旦随机对照试验（RCT）队列的主要疗效终点达到，将过渡到约 300 名接受 RDN 治疗的开放标签安全性队列。主要终点是从基线到 8 周（TARGET BP OFF-MED）和 3 个月（TARGET BP I）后 24 小时动态收缩压的平均变化。
TARGET BP 试验是首次大规模、国际性、随机试验，旨在研究使用 Peregrine 套件进行血管周围酒精输送的新型 RDN 方法的安全性和降压疗效。
