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希望才能完全实现 发现与不同人群及其临床医生相关并可以使用。慢性的 肾脏疾病（CKD）与高血压有关。非洲血统（AAS）的人最高 CKD和肾衰竭的风险，高血压的最高患病率和最低的血压率 （BP）控制。尽管这种差异部分是由于社会决定因素所致，但祖先具有生物学基础 AAS中几乎独有的APOL1高风险遗传变异增加了肾衰竭的风险10倍。作为 IGNITE II网络，我们将继续进行前瞻性随机务实的基因型引导 Guardd-US临床试验，以确定实施APOL1和降压的影响 有关高血压控制的药物基因组学测试。试验将确定早期与延迟的影响 对3个月收缩压（SBP）的阳性APOL1基因分型的了解会导致。审判旨在 有或没有CKD的高血压招募非裔美国人 APOL1基因检测的返回。在那些APOL1负面的人中，我们还将进行一项试点研究以测试 药物遗传学（PGX）测试对SBP的影响。次要结果包括CKD中的6个月SBP 患者在有序的药物下，肾脏诊断和测试患者心理行为结局 有效性以及PGX引导高血压管理对SBP的影响。我们期望成功 该临床试验的结果将提供推动基因组实施所需的关键证据 跨患者人口的广泛人口统计学。