Implementing genomic medicine through pragmatic trials in diverse and underserved populations across Indiana.

通过在印第安纳州不同且服务不足的人群中进行实用试验来实施基因组医学。

• 批准号: 10561225
• 负责人: Paul Dexter
• 金额: $ 16.64万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-03-01 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10561225
• 关键词: APOL1 gene; Adult; Affect; African American population; African ancestry; Antihypertensive Agents; Behavior; Biological; Blood Pressure; Chronic Kidney Failure; Clinical; Clinical Trials; Diagnosis; Genetic Risk; Genomic medicine; Genotype; Health; Healthcare; High Prevalence; Hypertension; Indiana; Individual; Kidney; Kidney Failure; Knowledge; Patient-Focused Outcomes; Patients; Persons; Pharmaceutical Preparations; Pharmacogenomics; Pilot Projects; Population; Population Heterogeneity; Provider; Randomized; Risk; Testing; Underserved Population; behavioral outcome; blood pressure control; cost effective; cost effectiveness; demographics; genetic information; genetic testing; genetic variant; high risk; hypertension control; improved; patient population; pharmacogenetic testing; pragmatic trial; prospective; recruit; secondary outcome; social determinants

The promise of genomic medicine to transform healthcare and improve health will not be fully realized until discoveries become relevant to and available for use by diverse populations and their clinicians. Chronic kidney disease (CKD) is associated with hypertension. People with African ancestry (AAs) have the highest risk of CKD and kidney failure, the highest prevalence of hypertension, and the lowest rate of blood pressure (BP) control. While this disparity is in part due to social determinants, ancestry has biological underpinnings and APOL1 high-risk genetic variants, nearly exclusive in AAs, increase kidney failure risk 10-fold. As part of the IGNITE II network, we will continue to conduct the prospective randomized pragmatic genotype-guided clinical trial, GUARDD-US, to determine the impact of implementing APOL1 and antihypertensive pharmacogenomic testing on hypertension control. The trial will determine the effect of early vs. delayed knowledge of a positive APOL1 genotyping result on 3-month systolic blood pressure (SBP). The trial aims to recruit African Americans with hypertension, with or without CKD, randomized to immediate versus delayed return of APOL1 genetic testing. In those who are APOL1 negative, we will also conduct a pilot study to test the impact of pharmacogenetic (PGx) testing on SBP. Secondary outcomes include 6-month SBP, in CKD patients, on medications ordered, renal diagnosis and testing patient psycho-behavioral outcomes, cost effectiveness, and the effect of PGX guided hypertension management on SBP. We expect the successful results from this clinical trial will provide critical evidence needed to drive the implementation of genomic medicine across broad demographics of patient populations.

基因组医学改变医疗保健和改善健康的承诺将不会完全实现，直到