ANTIHYPERTENSIVE THERAPY IN CHILDREN WITH ADPKD

ADPKD 儿童的抗高血压治疗

• 批准号: 7605052
• 负责人: MELISSA A CADNAPAPHORNCHAI
• 金额: $ 7.38万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2008-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7605052
• 关键词: Age; Amlodipine; Angiotensin-Converting Enzyme Inhibitors; Antihypertensive Agents; Autosomal Dominant Polycystic Kidney; Blood Pressure; Child; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Cystic kidney; Enalapril; End stage renal failure; Family; Funding; Gender; Grant; Growth; Height; Hydrochlorothiazide; Hypotension; Inflammatory; Institution; Kidney; Left Ventricular Mass; Magnetic Resonance Imaging; Measurement; Measures; Metoprolol; Microalbuminuria; Morbidity - disease rate; Numbers; Outcome; Pharmaceutical Preparations; Randomized; Recommendation; Research; Research Personnel; Resources; Screening procedure; Source; Standards of Weights and Measures; Testing; Ultrasonography; United States National Institutes of Health; blood pressure regulation; cytokine; indexing; mortality; normotensive; size; young adult

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 long-term objective of this research is to reduce the morbidity and mortality of autosomal dominant polycystic kidney disease (ADPKD). This study is a 5-year clinical trial to test the hypothesis that intensive blood pressure control with angiotensin converting enzyme inhibitors (ACEI) as first-line drugs will slow the progression of ADPKD in children. Progression in children will be measured by increase in renal volume, which reflects an increased number and size of renal cysts, as determined by ultrasonography. Secondary aims are: 1) to evaluate the effect of intensive blood pressure control on left ventricular mass index, on microalbuminuria, and on the activation level of several growth-related and inflammatory cytokines; and 2) to compare measurement of renal volume by ultrasonography and magnetic resonance imaging (MRI). Three groups of children and young adults, age 4 to 21 years, will be randomized to different treatments: 1. Hypertensive subjects with blood pressures above the 95th percentile for age-, gender- and height-matched children will be randomized to intensive or standard blood pressure control, with intensive control defined as lowering blood pressure to below 50th percentile and standard control as lowering blood pressure to 90th percentile. 2. Borderline hypertensive subjects with blood pressures between the 75th and 95th percentile will be randomized to treatment to lower the blood pressure to below 50th percentile or to no treatment. 3. Normotensive subjects (blood pressure between the 25th and 75th percentile) with severe ADPKD (SADPKD, defined as > 10 renal cysts) will be randomized to treatment with ACEI or to no treatment. The first-line drug for all groups is enalapril. Second-line drugs for groups 1 and 2 are amlodipine, metoprolol, and hydrochlorothiazide. The primary outcome variable is the increase in renal volume per year, compared between the different blood pressure levels or between ACEI treatment and no treatment. If intensive blood pressure control or treatment with ACEI can be shown to reduce progressive renal enlargement, it would change screening and treatment recommendations for children from ADPKD families and would have a major impact on the morbidity associated with enlarged kidneys and with end-stage renal disease in ADPKD.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 这项研究的长期目标是降低常染色体显性多囊肾脏疾病（ADPKD）的发病率和死亡率。这项研究是一项为期5年的临床试验，用于检验以下假设：作为一线药物将使用血管紧张素转化酶抑制剂（ACEI）的血压控制会减缓儿童ADPKD的进展。儿童的进展将通过肾脏体积的增加来衡量，这反映了超声检查确定的肾囊肿数量和大小的增加。 次要目的是：1）评估强化血压控制对左心室质量指数，微量珠尿症以及几种与生长有关和炎性细胞因子的激活水平的影响； 2）通过超声和​​磁共振成像（MRI）比较肾脏体积的测量。三组儿童和年轻人，4至21岁，将被随机分为不同的治疗方法：1。高于血压高于年龄，性别和身高匹配的儿童以上的血压高于95％的受试者，将随机分配到密集或标准的血压控制中，密集控制将血压定义为将血压定义为低于50％和标准对照，将血压降低到低于90％的血压。 2。具有血压在第75％到第95个百分位之间的临界高血压受试者将被随机进行治疗，以将血压降低至50％以下或无治疗。 3。具有严重ADPKD（SADPKD，定义为> 10个肾脏囊肿）的正常受试者（25％和75％的血压）将被随机分配给使用ACEI或无治疗。所有组的一线药物是依那普利。第1组和第2组的二线药物是氨氯地平，美托洛尔和氢氯噻嗪。主要结果变量是每年肾脏体积的增加，在不同的血压水平之间或ACEI治疗和无治疗之间进行了比较。如果可以证明强烈的血压控制或用ACEI治疗可以减少进行性肾脏肿大，则它将改变ADPKD家族的儿童的筛查和治疗建议，并对与肾脏增大和ADPKD中末期肾脏疾病相关的发病率产生重大影响。