The GUARDD-US study aims to determine the impact of disclosing genetic of kidney failure among adults with African ancestry on blood pressure. The GUARDD-US study team celebrated surpassing their enrollment goal on September 30, 2023 after enrolling 6,754 participants. The last participant is expected to complete the follow-up period for the trial by May 2024.

The study is a prospective, multicenter, unblinded, two-arm randomized pragmatic clinical trial investigating the impact of apolipoprotein L1 (APOL1) genotyping in patients with self-reported African ancestry who have been diagnosed with hypertension.

The study’s primary goal is to determine the effect of participant and provider knowledge of a high-risk APOL1 genotype on change in systolic blood pressure from baseline to 3 months after randomization. Secondary outcomes include kidney disease testing and psycho-behavioral factors.

Participants were randomized in a 1:1 ratio to immediate versus delayed APOL1 genotype testing with the return of results participants and providers.  A subset of the participants without high-risk APOL1 genotype were re-randomized to a genotype-guided approach to anti-hypertensive therapy versus usual care to determine the effect on three-month systolic blood pressure.

GUARDD-US was conducted across 11 relying sites and over 50 clinical practices in the United States.

Study results and primary manuscripts are anticipated to be released in late 2024.

More information about GUARDD-US can be found at https://clinicaltrials.gov/study/NCT04191824.