Genetic Testing to Understand and Address Renal Disease Disparities (GUARDD)

September 10, 2020 updated by: Carol R Horowitz, Icahn School of Medicine at Mount Sinai

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

2052

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10006
        • Institute for Family Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate Genetic Testing
Participants randomized to intervention will receive the APOL1 genetic test upon study enrollment.
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.
Other Names:
  • Genetic Risk Communication
No Intervention: Control- Delayed Testing
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Urine Protein Excretion
Time Frame: 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
Baseline and 12 months
Change in Systolic Blood Pressure
Time Frame: Baseline and 3 months
Change in systolic blood pressure at 3 months as compared to baseline
Baseline and 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Change in Medication Adherence
Time Frame: 3 months
Participant surveys (self-report) regarding medication adherence behaviors 3 months after randomization
3 months
Number of Patients With Changes in Psychosocial Behaviors
Time Frame: 3 months
Number of patients with changes in psychosocial behaviors 3 months after randomization
3 months
Number of Participants With Attitude Towards Genetic Testing
Time Frame: 3 months
Patient attitude towards genetic testing 3 months after randomization
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Icahn School of Medicine at Mount Sinai

Investigators

  • Principal Investigator: Erwin Bottinger, MD, MPH, Icahn School of Medicine at Mount Sinai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

January 12, 2018

Study Completion (Actual)

January 12, 2018

Study Registration Dates

First Submitted

September 4, 2014

First Submitted That Met QC Criteria

September 8, 2014

First Posted (Estimate)

September 9, 2014

Study Record Updates

Last Update Posted (Actual)

October 5, 2020

Last Update Submitted That Met QC Criteria

September 10, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCO 12-1143

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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