AGGRSSV RENIN-ANGIOTNSN-ALDOSTRN AXIS BLCKD IN PREVENT/SLOWING RENAL FNCTN DCLIN

AGGRSSV 肾素-血管-醛固酮轴 BLCKD 预防/减缓肾 FNCTN DCLIN

• 批准号: 7604462
• 负责人: ROBERT W SCHRIER
• 金额: $ 10.97万
• 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: 2007-07-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7604462
• 关键词: Age; Angiotensin Receptor; Angiotensin-Converting Enzyme Inhibitors; Autosomal Dominant Polycystic Kidney; Blinded; Blood Pressure; Blood Vessels; Blood typing procedure; Charge; Clinic Visits; Coin; Computer Retrieval of Information on Scientific Projects Database; Cyst; Cystic kidney; Enzymes; Funding; Glomerular Filtration Rate; Grant; Growth; Heart; Home Blood Pressure Monitoring; Hypertension; Hypotension; Institution; Kidney; Kidney Failure; Kidney Function Tests; Lisinopril; Magnetic Resonance Imaging; Monitor; Myocardium; Participant; Pharmaceutical Preparations; Population; Randomized; Renal function; Renin; Reporting; Research; Research Personnel; Resources; Screening procedure; Source; Standards of Weights and Measures; System; Testing; Thinking; Time; United States National Institutes of Health; Upper arm; Visit; Work; base; blood pressure regulation; medical examination; prevent; size; telmisartan

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. Hypertension, kidney cyst growth with corresponding increase in kidney size, and progression to kidney failure are concerns for people with autosomal dominant polycystic kidney disease (ADPKD). It is thought that hypertension and a corresponding increase in kidney cyst growth leads to kidney failure in this population. It is not known whether the type of blood pressure medication or the level of blood pressure control may slow cyst growth and delay kidney failure in people with ADPKD. This study, which attempts to answer these questions, is divided into two arms: Study A and Study B. Study A is for participants ages 15 to 49 years who have normal or low normal kidney function, defined as a glomerular filtration rate (GFR) of 60 ml/min/1.73 m2 or greater. Study B is for participants ages 18 to 64 years whose kidney function is below normal, defined as a GFR of 30-60 ml/min/1.73 m2. Study participants will be assigned to Study A or Study B based on their age and kidney function and will then be randomized at the "flip of a coin" into the various treatment groups. The table below summarizes both of these studies. Study A participants will be randomized into one of two blood pressure (BP) control and medication treatment groups. In the "low" BP group, BP will be maintained at 95-110/60-75 mm Hg using either lisinopril alone, a drug in the angiotensin converting enzyme inhibitor (ACE-I) group or the combination of the lisinopril (ACE-I) with telmisartan, a drug in the angiotensin receptor blocker (ARB) group. In the "standard" BP group, the BP will be maintained at 120-130/70-80 mm Hg using either the lisinopril alone or a lisinopril/telmisartan combination. Both of these drugs work on the kidney's enzyme system to control blood pressure. All Study B participants will be in the "standard" BP group (120-130/70-80 mm Hg ) and will be randomized to treatment with either lisinopril alone or with the lisinopril/telmisartan combination. All study medications, testing and medical examinations required in this study will be provided free of charge to participants. All medications in this study will be blinded to both the participants and researchers. Participants will be followed for a minimum of four years. They will provide regular home blood pressure monitoring reports and will make clinic visits at regular intervals (four times in the first year, and then every six months in the following years) for examination and kidney function testing. The Study A participants, will also have magnetic resonance (MR) imaging of their kidneys and hearts to monitor their kidney size, and blood vessels and their heart muscle size a total of three times during the study (screening visit, year two and year four). The table (below) summarizes both of these studies.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 高血压、肾囊肿生长以及肾脏大小相应增加以及进展为肾衰竭是常染色体显性多囊肾病 (ADPKD) 患者所关心的问题。据认为，高血压和肾囊肿生长的相应增加会导致该人群的肾衰竭。目前尚不清楚降压药物的类型或血压控制水平是否可以减缓 ADPKD 患者囊肿的生长并延缓肾衰竭。本研究试图回答这些问题，分为两个部分：研究 A 和研究 B。研究 A 适用于 15 至 49 岁、肾功能正常或较低的参与者，肾功能定义为肾小球滤过率 (GFR) 60 毫升/分钟/1.73 平方米或更大。研究 B 适用于 18 至 64 岁肾功能低于正常的参与者，定义为 GFR 为 30-60 ml/min/1.73 m2。研究参与者将根据年龄和肾功能被分配到研究 A 或研究 B，然后通过“掷硬币”的方式被随机分配到各个治疗组。下表总结了这两项研究。 研究 A 参与者将被随机分为两个血压 (BP) 控制组和药物治疗组之一。在“低”血压组中，使用单独的赖诺普利、血管紧张素转换酶抑制剂（ACE-I）组中的药物或赖诺普利（ACE-I）的组合将血压维持在95-110/60-75mmHg。 I) 联合替米沙坦，一种血管紧张素受体阻滞剂 (ARB) 组的药物。在“标准”血压组中，单独使用赖诺普利或使用赖诺普利/替米沙坦组合将血压维持在120-130/70-80 mm Hg。这两种药物都作用于肾脏的酶系统来控制血压。 所有研究 B 参与者均属于“标准”血压组（120-130/70-80 mm Hg），并将随机接受单独使用赖诺普利或联合使用赖诺普利/替米沙坦治疗。 本研究所需的所有研究药物、测试和体检将免费提供给参与者。 本研究中的所有药物将对参与者和研究人员均不知情。 参与者将被跟踪至少四年。他们将定期提供家庭血压监测报告，并定期（第一年四次，随后几年每六个月一次）到诊所进行检查和肾功能检测。研究 A 的参与者还将对其肾脏和心脏进行磁共振 (MR) 成像，以监测其肾脏大小、血管和心肌大小，在研究期间总共进行 3 次（筛选访视、第二年和第四年） ）。下表（如下）总结了这两项研究。