Genetic Testing to Understand and Address Renal Disease Disparities

Genomic Medicine Pilot for Hypertension and Kidney Disease in Primary Care

Sponsors

Lead Sponsor: Icahn School of Medicine at Mount Sinai

Source Icahn School of Medicine at Mount Sinai
Brief Summary

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 .

Detailed Description

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.

Overall Status Completed
Start Date November 2014
Completion Date January 12, 2018
Primary Completion Date January 12, 2018
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Increased utilization Change at 12 months as compared to 3 months
Change in systolic blood pressure Change at 12 months as compared to 3 months
Secondary Outcome
Measure Time Frame
Medication Adherence Change at 12 months as compared to 3 months
Quality of Life Change at 12 months as compared to 3 months
Attitudes towards genetic testing Change at 12 months as compared to 3 months
Enrollment 2052
Condition
Intervention

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

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Location
Facility:
Institute for Family Health | New York, New York, 10006, United States
Icahn School of Medicine at Mount Sinai | New York, New York, 10029, United States
Location Countries

United States

Verification Date

January 2018

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Immediate Genetic Testing

Type: Experimental

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).

Acronym GUARDD
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Double (Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov