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

被引：4

作者：

Eadon, Michael T. ^{[1
]}

Cavanaugh, Kerri L. ^{[2
]}

Orlando, Lori A. ^{[3
]}

Christian, David ^{[4
]}

Chakraborty, Hrishikesh ^{[3
,5
]}

Steen-Burrell, Kady-Ann ^{[5
]}

Merrill, Peter ^{[5
]}

Seo, Janet ^{[4
]}

Hauser, Diane ^{[4
,6
]}

Singh, Rajbir ^{[7
]}

Beasley, Cherry Maynor ^{[8
]}

Fuloria, Jyotsna ^{[9
]}

Kitzman, Heather ^{[10
]}

Parker, Alexander S. ^{[11
]}

Ramos, Michelle ^{[4
]}

Ong, Henry H. ^{[2
]}

Elwood, Erica N. ^{[12
]}

Lynch, Sheryl E. ^{[1
]}

Clermont, Sabrina ^{[4
]}

Cicali, Emily J. ^{[12
]}

Starostik, Petr ^{[13
]}

Pratt, Victoria M. ^{[1
]}

Nguyen, Khoa A. ^{[12
]}

Rosenman, Marc B. ^{[14
]}

Calman, Neil S. ^{[4
,6
]}

Robinson, Mimsie ^{[15
]}

Nadkarni, Girish N. ^{[16
]}

Madden, Ebony B. ^{[17
]}

Kucher, Natalie ^{[17
]}

Volpi, Simona ^{[17
]}

Dexter, Paul R. ^{[1
]}

Skaar, Todd C. ^{[1
]}

Johnson, Julie A. ^{[12
]}

Cooper-DeHoff, Rhonda M. ^{[12
,19
]}

Horowitz, Carol R. ^{[4
,16
,18
,19
]}

机构：

[1] Indiana Univ Sch Med, Indianapolis, IN 46202 USA

[2] Vanderbilt Univ Sch Med, Nashville, TN 37232 USA

[3] Duke Univ Sch Med, Durham, NC 27720 USA

[4] Inst Hlth Equ Res, Icahn Sch Med Mt Sinai, New York, NY 10029 USA

[5] Duke Clin Res Inst, Durham, NC 27720 USA

[6] Inst Family Hlth, New York, NY 10029 USA

[7] Meharry Med Coll, Nashville, TN 37208 USA

[8] Univ North Carolina Pembroke, McKenzie Elliott Sch Nursing, Pembroke, NC 28372 USA

[9] Univ Med Ctr New Orleans, Off Res, New Orleans, LA 70112 USA

[10] Baylor Univ, Robbins Inst Hlth Policy & Leadership, Baylor Scott & White Hlth, Dallas, TX 75246 USA

[11] Univ Florida Coll Med Jacksonville, Jacksonville, FL 32209 USA

[12] Univ Florida, Coll Pharm, Gainesville, FL 32610 USA

[13] Univ Florida, Coll Med, Gainesville, FL 32610 USA

[14] Northwestern Univ Feinberg Sch Med, Chicago, IL 60611 USA

[15] Bethel Gospel Assembly, New York, NY 10035 USA

[16] Icahn Sch Med Mt Sinai, Dept Med, New York, NY 10029 USA

[17] Natl Human Genome Res Inst, Div Genom Med, Bethesda, MD 20892 USA

[18] Internal Med Associates, 7th Floor 17 East 102nd St, New York, NY 10029 USA

[19] 1225 Ctr Dr, Gainesville, FL 32610 USA

来源：

CONTEMPORARY CLINICAL TRIALS | 2022年 / 119卷

基金：

美国国家卫生研究院;

关键词：

Investigators; Pharmacogenomics; Blood pressure; Genotype; Chronic kidney disease; BLOOD-PRESSURE; PRIMARY-CARE; INTERNATIONAL PROTOCOL; RACIAL DISPARITIES; ETHNIC DISPARITIES; EUROPEAN-SOCIETY; HEALTH; VALIDATION; DISEASE; RISK;

D O I：

10.1016/j.cct.2022.106813

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

Rationale and objective: 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.Study design: Multicenter, pragmatic, randomized controlled clinical trial. Setting and participants: 6650 individuals with African ancestry and hypertension from 13 health systems. Intervention: 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.Outcomes: 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.Results: To date, the trial has enrolled 3423 participants.Conclusions: 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. Trial registration: ClinicalTrials.gov NCT04191824

引用

页数：10

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