Genetic Testing to Understand and Address Renal Disease Disparities
Genomic Medicine Pilot for Hypertension and Kidney Disease in Primary Care
Lead Sponsor: Icahn School of Medicine at Mount Sinai
|Source||Icahn School of Medicine at Mount Sinai|
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 .
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.
|Start Date||November 2014|
|Completion Date||January 12, 2018|
|Primary Completion Date||January 12, 2018|
Intervention Type: Other
Intervention Name: Immediate Genetic Testing
Description: Participants will receive the APOL1 genetic test. Trained research staff will meet with participants to communicate results and lifetime ESRD risk attributable to variations in the APOL1 gene. Primary care providers will receive APOL1 genetic risk information via a best practice alert in the participant's EMR upon commencement of a patient encounter and through results filed in the participant's genetics results section of their EMR.
Arm Group Label: Immediate Genetic Testing
Other Name: Genetic Risk Communication
Inclusion Criteria: - Ages18-65 - Self-identifies as Black/African American - History of hypertension - Patient at a participating site Exclusion Criteria: - History of Chronic Kidney Disease - History of Diabetes - Pregnant - Cognitively impaired/unable to provide consent - Terminally ill - Planning to leave area of study permanently during the one year study period
- Self-identifies as Black/African American
- History of hypertension
- Patient at a participating site
- 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
Minimum Age: 18 Years
Maximum Age: 65 Years
Healthy Volunteers: Accepts Healthy Volunteers
|Has Expanded Access||No|
|Number Of Arms||2|
Label: Immediate Genetic Testing
Description: Participants randomized to intervention will receive the APOL1 genetic test upon study enrollment.
Label: Control- Delayed Testing
Type: No Intervention
Description: Participants randomized to control will not receive the APOL1 genetic test upon study enrollment. They will be offered the option to take the test during their final follow-up study visit (12 months post enrollment).
|Study Design Info||
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Masking: Double (Investigator, Outcomes Assessor)