Evidence map›Paper›PMID 35660539›Full record

ArticleContemporary clinical trials2022

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.

Michael T Eadon, Kerri L Cavanaugh, Lori A Orlando, David Christian, Hrishikesh Chakraborty, Kady-Ann Steen-Burrell, Peter Merrill, Janet Seo, Diane Hauser, Rajbir Singh and 26 more

2 registry-linked trialsOpen access · greenAbstract readClinical Trial Protocol
In one paragraph

Article in Contemporary clinical trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.2field-weighted citation impact, top 24% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04191824 nacompletednot on this map

Genetic Testing to Understand and Address Renal Disease Disparities Across the United States

TypeinterventionalSponsorDuke UniversityRan2020 to 2024Enrolled6,789ConditionsChronic Kidney Disease, HypertensionArmsTiming of return of results
NCT06748040 nacompletednot on this map

Genetic Testing to Understand and Address Renal Disease Disparities Across the United States - Pharmacogenetic Substudy

TypeinterventionalSponsorDuke UniversityRan2020 to 2024Enrolled1,874ConditionsChronic Kidney Disease, HypertensionArmsTiming of return of results
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
  2. Article
  3. Observational
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  8. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

36 authors at 15 institutions in 1 country.

Michael T EadonIndiana University School of Medicine, Indianapolis, IN 46202, USA.
Kerri L CavanaughVanderbilt University Medical Center, Nashville, TN 37232, USA.
Lori A OrlandoDuke University School of Medicine, Durham, NC 27720, USA.
David ChristianInstitute for Health Equity Research, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA.
Hrishikesh ChakrabortyDuke University School of Medicine, Durham, NC 27720, USA; Duke Clinical Research Institute, Durham, NC 27720, USA.
Kady-Ann Steen-BurrellDuke Clinical Research Institute, Durham, NC 27720, USA.
Peter MerrillDuke Clinical Research Institute, Durham, NC 27720, USA.
Janet SeoInstitute for Health Equity Research, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA.
Diane HauserInstitute for Health Equity Research, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA; Institute for Family Health, New York, NY 10029, USA.
Rajbir SinghMeharry Medical College, Nashville, TN 37208, USA.
Cherry Maynor BeasleyMcKenzie-Elliott School of Nursing, University of North Carolina at Pembroke, Pembroke, NC 28372, USA.
Jyotsna FuloriaOffice of Research, University Medical Center New Orleans, New Orleans, LA 70112, USA.
Heather KitzmanBaylor Scott & White Health, Baylor University, Robbins Institute for Health Policy & Leadership, Dallas, TX 75246, USA.
Alexander S ParkerUniversity of Florida College of Medicine - Jacksonville, Jacksonville, FL 32209, USA.
Michelle RamosInstitute for Health Equity Research, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA.
Henry H OngVanderbilt University Medical Center, Nashville, TN 37232, USA.
Erica N ElwoodUniversity of Florida, College of Pharmacy, Gainesville, FL 32610, USA.
Sheryl E LynchIndiana University School of Medicine, Indianapolis, IN 46202, USA.
Sabrina ClermontInstitute for Health Equity Research, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA.
Emily J CicaliUniversity of Florida, College of Pharmacy, Gainesville, FL 32610, USA.
Petr StarostikUniversity of Florida, College of Medicine, Gainesville, FL 32610, USA.
Victoria M PrattIndiana University School of Medicine, Indianapolis, IN 46202, USA.
Khoa A NguyenUniversity of Florida, College of Pharmacy, Gainesville, FL 32610, USA.
Marc B RosenmanNorthwestern University Feinberg School of Medicine, Chicago, IL 60611, USA.
Neil S CalmanInstitute for Health Equity Research, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA; Institute for Family Health, New York, NY 10029, USA.
Mimsie RobinsonBethel Gospel Assembly, New York, NY 10035, USA.
Girish N NadkarniDepartment of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA.
Ebony B MaddenDivision of Genomic Medicine, National Human Genome Research Institute, Bethesda, MD 20892, USA.
Natalie KucherDivision of Genomic Medicine, National Human Genome Research Institute, Bethesda, MD 20892, USA.
Simona VolpiDivision of Genomic Medicine, National Human Genome Research Institute, Bethesda, MD 20892, USA.
Paul R DexterIndiana University School of Medicine, Indianapolis, IN 46202, USA.
Todd C SkaarIndiana University School of Medicine, Indianapolis, IN 46202, USA.
Julie A JohnsonUniversity of Florida, College of Pharmacy, Gainesville, FL 32610, USA.
Rhonda M Cooper-DeHoffUniversity of Florida, College of Pharmacy, Gainesville, FL 32610, USA. Electronic address: dehoff@cop.ufl.edu.
Carol R HorowitzInstitute for Health Equity Research, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA; Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA. Electronic address: carol.horowitz@mountsinai.org.
GUARDD-US Investigators
Icahn School of Medicine at Mount Sinai · USUniversity of Florida · USIndiana University – Purdue University Indianapolis · USNational Human Genome Research Institute · USClinical Research Institute · USDuke University · USIndiana University School of MedicineVanderbilt University Medical Center · USBaylor Scott & White Health · USBethel University · USFlorida College · USMeharry Medical College · USNorthwestern University · USUniversity Medical Center New Orleans · USUniversity of North Carolina at Pembroke · US

Funding

Sparking Advancements in Genomic MedicineU01HG007269 · NHGRI · UNIVERSITY OF FLORIDA · PI CAVALLARI, LARISA HUMMA, JOHNSON, JULIE A. · 2013 to 2024
$17.0M
The IGNITE II CC: Engagement, Coordination, Demonstration, and DisseminationU01HG010225 · NHGRI · DUKE UNIVERSITY · PI CHAKRABORTY, HRISHIKESH, WYATT, CHRISTINA M · 2018 to 2024
$15.1M
Implementing genomic medicine through pragmatic trials in diverse and underserved populations across Indiana.U01HG010245 · NHGRI · INDIANA UNIVERSITY INDIANAPOLIS · PI DEXTER, PAUL, SKAAR, TODD C. · 2018 to 2024
$9.4M
GeNYC: Genomic Implementation Research in the Diverse Settings and Populations of New York CityU01HG010248 · NHGRI · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI HOROWITZ, CAROL R · 2018 to 2024
$9.0M
Integrated, Individualized, and Intelligent Prescribing (I3P) Clinical Trial NetworkU01HG010232 · NHGRI · VANDERBILT UNIVERSITY MEDICAL CENTER · PI CAVANAUGH, KERRI, PETERSON, JOSEPH F. · 2018 to 2024
$8.2M
IGNITE Cost Extension- Year 7U01HG010231 · NHGRI · DUKE UNIVERSITY · PI ORLANDO, LORI ANN · 2018 to 2024
$6.7M
COVID and Translational Science supercomputer (CATS)S10OD030463 · OD · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI KOVATCH, PATRICIA · 2021 to 2021
$2.0M
Big Omics Data Engine 2 SupercomputerS10OD026880 · OD · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI KOVATCH, PATRICIA · 2019 to 2019
$2.0M
NHGRI NIH HHS U01 HG007269NHGRI NIH HHS U01 HG010225NHGRI NIH HHS U01 HG010231NHGRI NIH HHS U01 HG010232NHGRI NIH HHS U01 HG010245NHGRI NIH HHS U01 HG010248NIH HHS S10 OD026880NIH HHS S10 OD030463
6 · The paper itself

Abstract

RATIONALE AND

objectiveAPOL1 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

designMulticenter, pragmatic, randomized controlled clinical trial. SETTING AND

participants6650 individuals with African ancestry and hypertension from 13 health systems.

interventionAPOL1 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.

resultsTo date, the trial has enrolled 3423 participants.

conclusionsThe 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 registrationClinicalTrials.govNCT04191824.

Indexed as

HypertensionRenal Insufficiency, ChronicAntihypertensive AgentsApolipoprotein L1Black or African AmericanBlood PressureGenetic TestingHumansMulticenter Studies as TopicPharmacogeneticsPragmatic Clinical Trials as TopicRandomized Controlled Trials as TopicAntihypertensive AgentsAPOL1 protein, humanApolipoprotein L1Blood pressureChronic kidney diseaseGenotypePharmacogenomics

Identifiers

PMID35660539
PMCPMC9928488
OpenAlexW4281716153

What Socratic holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.