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直到 这些发现变得与不同的人群及其临床医生相关并可供其使用。慢性 肾脏疾病(CKD)与高血压有关。非洲血统的人(AA)拥有最高的 患慢性肾脏病和肾功能衰竭的风险最高，高血压患病率最高，血压患病率最低 (BP)控制。虽然这种差异在一定程度上是由社会决定因素造成的，但祖先有生物学基础。 而APOL1高危基因变异，几乎是AAs中的独有，会使肾衰竭风险增加10倍。作为以下内容的一部分 在IGNITE II网络中，我们将继续进行前瞻性、随机化、实用化的基因引导 临床试验，GUARDD-US，以确定实施APOL1和降压的影响 高血压控制的药物基因组学检测。这项试验将确定提前和推迟的效果。 了解APOL1基因分型结果对3个月收缩压(SBP)的影响。审判的目的是为了 招募患有高血压的非裔美国人，有或没有CKD，随机分为立即组和延迟组 返回APOL1基因检测。对于那些APOL1阴性的人，我们还将进行一项试点研究，以测试 药物遗传学(PGx)试验对SBP的影响。次要结果包括CKD患者6个月的SBP 患者，订购药物，肾脏诊断和检测患者的心理行为结果，费用 Pgx引导下的高血压治疗对SBP的影响。我们期待成功的 这项临床试验的结果将提供推动基因组学实施所需的关键证据 在患者群体的广泛人口统计中的医学。