About this trial
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 criteria
Qualifiers
≥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.
Hypertension diagnosis within the past 18 months prior to screening.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- observational study
Treatment groups
Sponsors and collaborators
Kaiser Permanente
Lead sponsor
AstraZeneca
Collaborator