Genetic Testing to Understand and Address Renal Disease Disparities

Hypertension Clinical Trial

— GUARDD  

Official title:

Genomic Medicine Pilot for Hypertension and Kidney Disease in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02234063
• Other study ID #: GCO 12-1143
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: January 12, 2018

Study information

• Verified date: September 2020
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2052
• Est. completion date: January 12, 2018
• Est. primary completion date: January 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Genomics
• Hypertension
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Immediate Genetic Testing
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.

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Institute for Family Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Urine Protein Excretion	Number of participants with urine protein excretion in urine tests to assess kidney function at 12 months as compared to baseline	Baseline and 12 months
Primary	Change in Systolic Blood Pressure	Change in systolic blood pressure at 3 months as compared to baseline	Baseline and 3 months
Secondary	Number of Participants With Change in Medication Adherence	Participant surveys (self-report) regarding medication adherence behaviors 3 months after randomization	3 months
Secondary	Number of Patients With Changes in Psychosocial Behaviors	Number of patients with changes in psychosocial behaviors 3 months after randomization	3 months
Secondary	Number of Participants With Attitude Towards Genetic Testing	Patient attitude towards genetic testing 3 months after randomization	3 months

External Links

•   Implementing GeNomics In PracTicE (IGNITE) Network Website