跳至主要内容
临床试验/NCT02234063
NCT02234063已完成不适用

Genomic Medicine Pilot for Hypertension and Kidney Disease in Primary Care

Icahn School of Medicine at Mount Sinai2 个研究点 分布在 1 个国家目标入组 2,052 人开始时间: 2014年11月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carol R Horowitz

Professor

Icahn School of Medicine at Mount Sinai

研究点 (2)

Loading locations...

相似试验