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Abstract: FR-PO320

Design and Rationale of GUARDD-US: A Pragmatic, Randomized Trial of Genetic Testing for APOL1 and Pharmacogenomic Predictors of Antihypertensive Efficacy in Patients With Hypertension

Session Information

Category: Genetic Diseases of the Kidneys

  • 1102 Genetic Diseases of the Kidneys: Non-Cystic


  • Eadon, Michael T., Indiana University School of Medicine, Indianapolis, Indiana, United States
  • Cavanaugh, Kerri L., Vanderbilt University, Nashville, Tennessee, United States
  • Nadkarni, Girish N., Icahn School of Medicine at Mount Sinai, New York, New York, United States
  • Cooper-DeHoff, Rhonda M., University of Florida, Gainesville, Florida, United States
  • Horowitz, Carol, Icahn School of Medicine at Mount Sinai, New York, New York, United States

Group or Team Name


APOL1 risk alleles are associated with increased cardiovascular and chronic kidney disease (CKD) risk. It is unknown whether knowledge of APOL1 risk status motivates patients and providers to attain recommended blood pressure (BP) targets to reduce cardiovascular disease.


This is a multicenter, pragmatic, randomized controlled clinical trial of 6650 individuals with African ancestry and hypertension from 13 health systems. APOL1 genotyping with clinical decision support (CDS) results are returned to participants and providers immediately (intervention) or at 6 months (control). A subset of participants are re-randomized to pharmacogenomic testing for relevant antihypertensive medications (pharmacogenomic sub-study). CDS alerts encourage appropriate CKD screening and antihypertensive agent use. Blood pressure and surveys are assessed at baseline, 3 and 6 months. The primary outcome is change in systolic BP from enrollment to 3 months in individuals with two APOL1 risk alleles. Secondary outcomes include new diagnoses of CKD, systolic blood pressure at 6 months, diastolic BP, and survey results. The pharmacogenomic sub-study will evaluate the relationship of pharmacogenomic genotype and change in systolic BP between baseline and 3 months.


As of January 2022, the trial had enrolled 3423 participants.


The effect of patient and provider knowledge of APOL1 genotype on systolic blood pressure has not been well-studied. GUARDD-US addresses whether blood pressure improves when patients and providers have this information. GUARDD-US provides a CDS framework for primary care and specialty clinics to incorporate APOL1 genetic risk and pharmacogenomic prescribing in the electronic health record.


  • Other NIH Support