Genetic Testing to Understand and Address Renal Disease Disparities Across the United States Phar… (NCT06748040) | Clinical Trial Compass
CompletedNot Applicable
Genetic Testing to Understand and Address Renal Disease Disparities Across the United States Pharmacogenetic Substudy
United States1,874 participantsStarted 2020-07-10
Plain-language summary
This is a substudy of GUARDD-US (Genetic testing to Understand and Address Renal Disease Disparities across the United States, NCT04191824). Its primary purpose is to determine the effect of knowledge of genetic test results that predict efficacy of various antihypertensive medications on change in SBP (systolic blood pressure) from baseline to 3 months in APOL1 (apolipoprotein L1) negative individuals at participating sites.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Self reported African ancestry
* English Speaking
* Age 18-70 years
* Have diagnosis of hypertension: Diagnosis of hypertension is defined by either:
* ICD10 diagnosis codes (i.e., I10; I11.x; I12.x; I13.x; I16.x) OR
* On active antihypertensive therapy for indication of hypertension OR
* Having systolic blood pressure of 140 mm Hg or greater in at least 2 of the last 3 consecutive recorded values in the EHR OR
* Having hypertension in the patient's medical record problem list
* Have been seen at ≥1 time in past year at a participating primary care site
* Either: 1) do not have diabetes and do not have CKD, or 2) have CKD; Participants with diabetes may be included as long as they also have CKD.
CKD is defined by either: A) ICD10 codes (i.e., N18.x; E08.22; E09.22; E10.22; E11.22;E13.22 (exclude Z94.0; N18.6; Z99.2)) OR B) Microalbumin/proteinuria level \>30 mg/g for 2 time periods ≥ 3 months. Values taken within 12 months of enrollment, unless 2 values are unavailable, then review within 24 months of enrollment. OR C) 15 ≤ eGFR ≤ 60 ml/min for 2 time periods ≥ 3 months. GFRs are taken within 12 months of enrollment, unless 2 values are unavailable, then review within 24 months.
Diabetes is defined by: HbA1c ≥ 6.5 at least one time in the last year OR ICD10 diagnosis codes OR Having diabetes in the patient's medical record problem list.
Exclusion Criteria:
* Have diabetes, but no CKD.
* Are currently on dialysis (ICD 10 codes N18.6, Z99.2 a…
What they're measuring
1
Change in Systolic Blood Pressure From Baseline to 3 Months for APOL1 Negative Participants