Adjunctive Rosuvastatin Treatment for prEventing coMplIcationS In Renal Ablation
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Optical coherence tomography evidence of vascular injury induced by radiofrequency
研究概览
简要总结
The primary objective of this study is to test the hypothesis that twice overnight high-dose rosuvastatin loading before RNA followed by 3-month treatment with regular doses of rosuvastatin can reduce both the acute and late renal artery damage.
详细描述
Despite the availability and use of different classes of antihypertensive drugs, 5-30% of patients still show elevated blood pressure (EUROASPIRE III survey, 2011).
Recently, a novel catheter-based radiofrequency ablation technique has been developed allowing for renal nerve ablation (RNA). Currently, two different catheter-based systems are primarily used (Simplicityw catheter by Medtronic-Adrian and the EnligHTNTM multi-electrode RNA catheter from St Jude Medical).
The RNA technique has been associated with a very low complication rate, but the development of a renal artery stenosis after RNA has been reported (J Am Coll Cardiol 2012;60:2694-2695).
Although little is known about the vascular injury induced by the RNA procedure at the site of ablation, a recent study has reported for the first time the evidence at optical coherence tomography (OCT) of local vascular injury induced by the radiofrequency energy. Such local tissue damage, which is not apparent with angiography, is characterized by local and diffuse vasospasm, oedema formation, and endothelial injury with thrombus generation (Templin et al. Eur Heart J, 25 April 2012).
Experimental research have suggested that these abnormalities are only present in the acute phase immediately after RNA and seem to be the consequence of a transient phenomenon of inflammation (Clin Res Cardiol 2011;100:1095-1101), similarly to what occurs in the coronary arteries after percutaneous coronary intervention (PCI).
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
- Single (Participant)
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
- •Primary and idiopathic cause of resistant arterial hypertension defined as persistent systolic blood pressure persistent systolic blood pressure - 160 mm Hg, with at least established three antihypertensive medication (including diuretics)
- •Patients with allergies to antihypertensive drugs
- •Able to understand and willing to sign the informed CF
排除标准
- •Glomerular filtration rate <45 mL/min
- •LDL Cholesterol >130 mg/dl
- •Presence of coronary artery disease
- •History of myopathy or elevated creatine kinase levels
- •History of Impaired liver function and/or elevated ALT and/or AST levels
- •Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT
研究组 & 干预措施
Rosuvastatin Group
Patients will be randomized to receive two overnight high doses of Rosuvastatin (40 mg 12 h before RNA and another 10 mg dose 2 h before the procedure
干预措施: Rosuvastatin (Drug)
Placebo group
Patients will be randomized to receive two overnight high doses of Placebo before RNA and another placebo dose 2 h before the procedure
干预措施: Placebo (Drug)
结局指标
主要结局
Optical coherence tomography evidence of vascular injury induced by radiofrequency
时间窗: Up to 3 months
Evidence at optical coherence tomography of at least one of the following abnormalities: * Presence (vs. absence) of local and diffuse vasospasm (i.e. as defined by immediate loss of lumen area or lumen diameter in any part of renal artery) * Presence (vs.r absence) of oedema formation * Presence (vs. absence) of endothelial injury
次要结局
- Post-procedural changes in renal function(Up to 48 hours)
研究者
Francesco Pelliccia
Assistant Professor
University of Roma La Sapienza