ANTIHYPERTENSIVE THERAPY IN AUTOSOMAL DOMINANT PKD

常染色体显性多囊肾的抗高血压治疗

• 批准号: 6232463
• 负责人: ROBERT W SCHRIER
• 金额: $ 34.53万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-04-01 至 2006-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6232463
• 关键词: ACE inhibitors; adolescence (12-20); autosomal dominant trait; blood chemistry; cardiovascular disorder chemotherapy; chemoprevention; child (0-11); clinical trials; cytokine; human morbidity; human subject; human therapy evaluation; hypertension; kidney disorder chemotherapy; kidney imaging /visualization; patient oriented research; polycystic kidney

DESCRIPTION (the applicant's description verbatim): The long-term objective of this research is to reduce the morbidity and mortality of autosomal dominant polycystic kidney disease (ADPKD). This project is an on-going 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 as determined by ultrasound imaging, reflecting increased number and size of renal cysts. Secondary aims are to evaluate the effect of intensive blood pressure control on left ventricular mass index, on microalbuminuria and proteinuria, and on the activation level of several growth-related and inflammatory cytokines. 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 the 45th to 50th percentile and standard control as lowering blood pressure to the 85th 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 the 45th to 50th percentile versus no treatment. 3. Normotensive subjects (blood pressure between the 25th and 75th percentile) will be randomized to treatment with ACEI as long as blood pressure stays above the 25th percentile versus no treatment. The first-line drug for all groups is enalapril, second-line drugs for groups 1 and 2 are amlodipine and hydrochiorothiazide. The primary outcome variable is the increase in renal volume per year, compared between the different treatment levels or between treatment and no treatment. If intensive blood pressure control 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 large kidneys and with end-stage renal disease in ADPKD.

描述（申请人的描述逐字描述）： 这项研究是为了降低常染色体显性的发病率和死亡率 多囊肾脏疾病（ADPKD）。该项目是一个正在进行的5年临床 试验以检验以下假设： 血管紧张素转化酶抑制剂（ACEI）作为一线药物会减慢 儿童ADPKD的进展。将测量儿童的进展 通过超声成像确定的肾小量增加，反映 肾脏囊肿的数量和大小增加。次要目的是评估 强化血压控制对左心室质量指数的影响，对 微量白蛋白尿和蛋白尿，在几个激活水平上 生长有关和炎症细胞因子。三组儿童和年轻 4至21岁的成年人将被随机分配给不同的治疗方法：1。 高血压受试者的血压高于年龄高于第95个百分点 性别匹配和身高匹配的孩子将被随机分配到密集或标准 血压控制，密集控制定义为降低血液 降低血液的压力达到第45％至50％和标准控制 压力达到第85至90个百分位。 2。边缘性高血压学科 在第75％到第95个百分位之间的血压将随机分为 治疗以降低血压至第45％至50％ 治疗。 3。正常的受试者（第25至75位的血压 只要血压 保持在第25个百分位数与没有治疗的高度。一线药物 所有组均为依那普利，第1组和第2组的二线药物是氨氯地平 和氢化硫代嗪。主要结果变量是肾脏的增加 每年的体积，在不同的治疗水平之间或之间 治疗和没有治疗。如果可以显示强化血压控制 减少进行性肾脏扩大，它将改变筛查和治疗 针对来自ADPKD家庭的儿童的建议，并将产生重大影响 关于与大型肾脏和末期肾脏疾病有关的发病率 在ADPKD中。