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REFOCUS-HTN US-WEST: A Data Infrastructure to Characterize Individuals With Hypertension

RecruitingN/A

Sponsor: Kaiser Permanente

Conditions: Hypertension, Aldosterone Disorder, Cardiovascular Disease (CVD)

Interventions: observational study

Countries: United States

The goal of the REFOCUS-HTN US-WEST program is to gain a better understanding of the role of a hormone called aldosterone in the development of hypertension. The SCALED sub-study is an observational cohort study that will enroll from REFOCUS-HTN cohort for prospective data collection.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

The SCALED Cohort will be identified from the REFOCUS-HTN Cohort which includes men and women ≥ 18 years of age with established hypertension in the KPNC EHR from January 2012 through March 31, 2029. Established hypertension will be defined as one of the following:

* ≥1 outpatient, non-emergency department diagnosis of hypertension;
* ≥2 consecutive outpatient measures of systolic blood pressure ≥130 mmHg at least 90 days apart;
* ≥2 consecutive outpatient measures of diastolic blood pressure ≥80 mmHg at least 90 days apart.

Additional Eligibility Criteria for SCALED:

* Hypertension diagnosis within the past 18 months prior to screening.
* At least 6 months of continuous health plan coverage prior to initial visit.

Exclusion Criteria:

* Diagnosed cause of secondary hypertension from drug or alcohol induced, or renovascular hypertension;
* Bariatric surgery or GLP1 prescription in the last 12 months;
* Exposure to an aldosterone synthase inhibitor or a mineralocorticoid receptor antagonist in the last 12 weeks;
* Last known estimated glomerular filtration rate \< 45 mL/min/1.73m2 (according to the CKD-EPI equation) at the time of screening;
* Kidney transplant;
* Currently receiving dialysis;
* Current enrollment in any cardiovascular or blood pressure interventional trial.

Locations (1)

Oakland, California, United States