Genomic Medicine Pilot for Hypertension and Kidney Disease in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,052
- 试验地点
- 2
- 主要终点
- Number of Participants With Urine Protein Excretion
研究概览
简要总结
In this genomic medicine implementation pilot project, the investigators aim to conduct a randomized trial in a network of community health centers and primary care facilities to study processes, effects and challenges of incorporating information for apolipoprotein L1 (APOL1)-attributable genetic risk for end stage kidney disease in patients of African ancestry with hypertension .
详细描述
CKD is most commonly associated with diabetes (40%) and hypertension (28%), and affects 26 million American adults. African ancestry populations with hypertension (HTN) have 2- to 3-fold higher risk of developing CKD, and a 5-fold increased risk to progress to end stage renal disease (ESRD) when compared with whites. HTN is a risk factor for progression of CKD and for increased cardiovascular risk with CKD. Thus targeting blood pressure control as a modifiable risk factor may both reduce CVD in people with CKD and reduce progression of CKD to end stage disease. Recent discoveries demonstrate that testable alleles of the APOL1 locus on chromosome 22 have a major effect on and explain almost all of the excess risk for hypertension-associated CKD and its progression to ESRD in African ancestry populations.
We will use community-engaged approaches to enroll patients of African Ancestry with HTN from a network of community health centers and primary care facilities in Harlem and the Bronx and randomize them on a 7 to 1 ratio to receive APOL1 genetic testing and EMR-enabled provider clinical decision support incorporating APOL1 genomic risk information.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages18-65
- •Self-identifies as Black/African American
- •History of hypertension
- •Patient at a participating site
排除标准
- •History of Chronic Kidney Disease
- •History of Diabetes
- •Cognitively impaired/unable to provide consent
- •Terminally ill
- •Planning to leave area of study permanently during the one year study period
结局指标
主要结局
Number of Participants With Urine Protein Excretion
时间窗: Baseline and 12 months
Number of participants with urine protein excretion in urine tests to assess kidney function at 12 months as compared to baseline
Change in Systolic Blood Pressure
时间窗: Baseline and 3 months
Change in systolic blood pressure at 3 months as compared to baseline
次要结局
- Number of Participants With Change in Medication Adherence(3 months)
- Number of Patients With Changes in Psychosocial Behaviors(3 months)
- Number of Participants With Attitude Towards Genetic Testing(3 months)
研究者
Carol R Horowitz
Professor
Icahn School of Medicine at Mount Sinai
