Genetic Testing to Understand and Address Renal Disease Disparities



Status:Completed
Conditions:High Blood Pressure (Hypertension), Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:Cardiology / Vascular Diseases, Nephrology / Urology
Healthy:No
Age Range:18 - 65
Updated:1/20/2018
Start Date:November 2014
End Date:January 12, 2018

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Genomic Medicine Pilot for Hypertension and Kidney Disease in Primary Care

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.

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
We found this trial at
2
sites
New York, New York
Principal Investigator: Neil Calman, MD
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Principal Investigator: Erwin Bottinger, MD
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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