GUARDD-US is a study of how Apolipoprotein L1 (APOL1) genotyping affects African American patients with high blood pressure.

GUARDD-US White Logo [Large 2]

Study Overview

Status
Completed

Timeline
July 2020 – May 2024

Design
Prospective, multicenter, unblinded, two-arm randomized pragmatic clinical trial. Randomized to immediate (intervention) vs. delayed (control) return of results for positive or negative APOL1 status.

Intervention / Treatment
Diagnostic Test: APOL1 status

Sponsor
National Human Genome Research Institute (NHGRI)

QUICK LINKS

MAIN STUDY

To learn how awareness of a high-risk APOL1 genotype, supported by guideline-based clinical decision support (CDS) for blood pressure management, affects changes in systolic blood pressure (SBP) over three months post-randomization. Secondary outcomes include kidney disease testing and psycho-behavioral factors among participants testing positive for APOL1 within the randomized population. For more information about the GUARDD-US main trial, visit the ClinicalTrials.gov page: Main Trial

PGx SUBSTUDY

To assess how knowledge of genetic test results predicting the effectiveness of different blood pressure medications influences changes in SBP from baseline to 3 months in a subset of the individuals who test negative for APOL1. For more information about the GUARDD-US PGx substudy, visit the ClinicalTrials.gov page: GUARDD-US PGx Substudy.

PARTICIPATION CRITERIA

  • Ages 18-70
  • English speaking
  • Self-reported African ancestry
  • Diagnosed with high blood pressure

PRINCIPAL INVESTIGATOR

  • Carol Horowitz, MD, MPH
    Professor of Population Health Science & Policy and Medicine
    Center for Community and Academic Research Partnerships
    Mount Sinai Icahn School of Medicine