Universitätskliniken des Saarlandes, Klinik für Innere Medizin III, Homburg/Saar, Germany.
EuroIntervention. 2013 Aug 22;9(4):484-92. doi: 10.4244/EIJV9I4A78.
Hypertension is a global healthcare concern associated with a wide range of comorbidities. The recognition that elevated sympathetic drive plays an important role in the pathogenesis of hypertension led to the use of renal artery denervation to interrupt the efferent and afferent sympathetic nerves between the brain and kidneys to lower blood pressure. Clinical trials of the Symplicity™ renal denervation system have demonstrated that radiofrequency ablation of renal artery nerves is safe and significantly lowers blood pressure in patients with severe resistant (systolic BP >160 mmHg) hypertension. Smaller ancillary studies in hypertensive patients suggest a benefit from renal denervation in a variety of conditions such as chronic kidney disease, glucose intolerance, sleep apnoea and heart failure.
The Global SYMPLICITY registry, which incorporates the GREAT SYMPLICITY registry initiated in Germany, is being conducted worldwide to evaluate the safety and efficacy of treatment with the Symplicity renal denervation system in real-world uncontrolled hypertensive patients, looking first at subjects with severe resistant hypertension to confirm the results of prior clinical trials, but then also subjects with a wider range of baseline blood pressure and coexisting comorbidities.
The rationale, design and first baseline data from the Global SYMPLICITY registry are presented.
高血压是一种全球性的医疗保健关注点，与多种合并症相关。认识到升高的交感神经驱动在高血压发病机制中起着重要作用，导致使用肾动脉去神经支配来中断大脑和肾脏之间的传出和传入交感神经，以降低血压。Symplicity™肾去神经系统的临床试验表明，射频消融肾动脉神经是安全的，并可显著降低严重难治性（收缩压>160mmHg）高血压患者的血压。高血压患者的较小辅助研究表明，肾去神经支配在各种情况下都有益，如慢性肾脏病、葡萄糖耐量异常、睡眠呼吸暂停和心力衰竭。
全球 SYMPLICITY 注册研究纳入了在德国启动的 GREAT SYMPLICITY 注册研究，正在全球范围内进行，以评估 Symplicity 肾去神经系统治疗在真实世界中未控制的高血压患者中的安全性和疗效，首先关注严重难治性高血压患者，以确认先前临床试验的结果，然后还关注基线血压范围更广和并存合并症的患者。
呈现了全球 SYMPLICITY 注册研究的原理、设计和首次基线数据。
