CLINICAL TRIAL: SHARP

这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 心脏和肾脏保护研究（SHARP）将评估辛伐他汀和胆固醇吸收抑制剂依折麦布联合治疗的效果。9，000例慢性肾病（CKD）患者-随机分组时，约6，000例患者将接受透析前治疗，3，000例患者将接受透析治疗。首先，在透析患者中进行的观察性研究报告了血液总胆固醇与死亡率之间的负相关性。其次，在这些患者中，只有大约四分之一的心脏死亡似乎明确归因于急性心肌梗死，并且通过降低胆固醇可能可以避免，而其他常见原因（例如心脏骤停，心律失常和心力衰竭）可能不依赖于胆固醇水平。最后，CKD患者降低胆固醇的长期安全性仍不清楚。 SHARP的主要目的是评估辛伐他汀20 mg和依折替胺10 mg联合治疗与安慰剂相比降低LDL胆固醇对至首次重大血管事件（定义为非致死性心肌梗死或心源性死亡、非致死性或致死性卒中或血运重建）时间的影响。本研究的次要目的包括评估依折麦布/辛伐他汀对以下方面的影响：进展至终末期肾病（在透析前患者中）;各种死亡原因;重大心脏事件（定义为非致死性MI或心源性死亡）;卒中和因心绞痛住院治疗。 50例受试者将在Meharry入组本研究，包括透析前和透析患者。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The Study of Heart and Renal Protection (SHARP) will assess the effects of a combination of simvastatin and the cholesterol-absorption inhibitor ezetimibe among approx. 9,000 patients with chronic kidney disease (CKD) -around 6,000 of who will be pre-dialysis and 3,000 on dialysis at randomization. First, observational studies among dialysis patients have reported a negative association between blood total cholesterol and mortality. Secondly, only about one quarter of cardiac mortality in such patients appears to be definitely attributable to acute myocardial infarction, and potentially avoidable with cholesterol-lowering, while the other common causes (e.g. cardiac arrest, arrhythmia, and heart failure) may not be as dependent on cholesterol levels. Finally, the long-term safety of cholesterol reduction among patients with CKD remains unclear. The primary aim of SHARP is to assess the effects of lowering LDL cholesterol with combined simvastatin 20 mg and ezetimide 10 mg versus placebo on the time to a first major vascular event (defined as non-fatal myocardial infarction or cardiac death, non-fatal or fatal stroke, or revascularisation). Secondary aims of the study include an assessment of the effects of ezetimibe/simvastatin on: progression to end-stage renal disease (among pre-dialysis patients); various causes of death; major cardiac events (defined as non-fatal MI or cardiac death); stroke and hospitalization for angina. Fifty subjects will be entered into this study at Meharry, including pre-dialysis and dialysis patients.