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: 7377870
• 负责人: ROBERT W SCHRIER
• 金额: $ 0.53万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-01 至 2007-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7377870
• 关键词: AGGRSSV; RENIN; ANGIOTNSN; ALDOSTRN; AXIS; AGGRSSV; RENIN; ANGIOTNSN; ALDOSTRN; AXIS

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NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。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。列出的机构适用于该中心，这不一定是调查员的机构。高血压，肾脏囊肿生长，肾脏大小的相应增加以及肾衰竭的进展是常染色体显性多囊肾脏病（ADPKD）的人们的关注点。人们认为高血压和肾脏囊肿生长的相应增加会导致该人群的肾衰竭。尚不清楚血压药物的类型或血压控制水平是否会减慢ADPKD患者的囊肿生长和延迟肾衰竭。试图回答这些问题的这项研究分为两个臂：研究A和研究B。研究A是针对15至49岁的参与者，他们具有正常或低正常肾功能，定义为肾小球过滤率（GFR）为60 mL/min/min/min/1.73 m2或更高。研究B适用于18至64岁的参与者的肾功能低于正常功能，定义为30-60 mL/min/1.73 m2的GFR。研究参与者将根据其年龄和肾脏功能分配研究A或研究B，然后将“硬币翻转”随机分为各种治疗组。下表总结了这两项研究。 研究A将随机分为两个血压（BP）控制和药物治疗组之一。在“低” BP组中，仅使用任何一种lisinopril，血管紧张素转化酶抑制剂（ACE-I）组的药物或lisinopril（ACE-I）与TelmisArtan，A telmisartan，A AngiotenInCoctors blakerer the Angiotensin Clageer（Arb）组合，BP将维持在95-110/60-75 mm Hg。在“标准” BP组中，BP将使用单独的赖诺普利或Lisinopril/telmisartan组合保持120-130/70-80 mm Hg。这两种药物都在肾脏的酶系统上起作用以控制血压。 所有研究b参与者将位于“标准” BP组（120-130/70-80 mm Hg）中，并将单独或lisinopril/telmisartan组合随机分配给使用赖诺普利的治疗。 本研究中需要的所有研究药物，测试和体检将免费提供给参与者。 这项研究中的所有药物将对参与者和研究人员视而不见。参与者将至少遵循四年。他们将提供定期的家庭血压监测报告，并定期进行诊所就诊（第一年为四次，然后在接下来的几年中每六个月）进行检查和肾脏功能测试。该研究的参与者还将对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三次（筛查访问，二年级和四年级）。表（下表）总结了这两项研究。