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.
Showing the most recent 10 out of 1065 publications
