Prospective renal insufficiency cohort evaluation: PRICE

项目总结

PROJECT SUMMARY The CRIC Study was initiated in 2001 and enrolled its first participants in mid 2003. In the intervening years the CRIC Study has consistently met recruitment goals in Phase 1 and Phase 3, and maintained a high level of participant follow up during the study. We have published over 150 manuscripts and are entering the potential for a fourth phase (2018-2023) of funding during which we hope to follow up the newly recruited participants from Phase 3 (2013-2017; n=1520) and those from Phase 1 (2003-2008; n=3939) who are still active in the study. We propose 12 Specific Aims that are common to each clinical center in this competing U01 renewal application and provide background and methodology to incorporate and number of new measurements into the CRIC Study. In particular, we are adding innovative measures that record 48 hours of heart rate variability, physical activity by accelerometry and breathing rate via the Zephyr BioPatch, and 14 days of continuous ECG monitoring via the ZIO XT Patch. In addition, we plan obtain measures of in-home monitoring for subclinical episodes of AKI using current technologies that allow a fingerstick creatinine measurement and urine protein, albumin and creatinine measures to be obtained at home and uploaded to the CRIC clinical center. In this application we will focus on our Center's productivity in the CRIC study and in particular will showcase the remarkable opportunity available in the understanding of heart failure, the single most common CV endpoint in the CRIC study, through biometric monitoring using these new technologies, along with our site's experience with a pilot study in this area. In this application we will review important aspects of CKD and contributions of our clinical center to the CRIC effort. This application includes a progress report from our site (101) as well as proposals for data sharing and the recruitment of investigators at our Institution as well as outside our Institution to participate in evaluating and publishing findings from this landmark study in the Nephrologic Community that will further the mission of the NIDDK to promote kidney health and to design interventions that mitigate the burden of CKD in the US adult populations with CKD.