Aldosterone Disorder, Cardiovascular Disease (CVD), Hypertension
Conditions
Keywords
Hypertension, Aldosterone, aldosterone dysregulation, aldosterone disorder, cardiovascular disease (CVD)
Brief summary
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.
Detailed description
Recent 2025 American Heart Association (AHA) guidelines recommend lower blood pressure targets for individuals with increased cardiovascular risk. Importantly, they recommend primary aldosteronism screening for all patients with resistant hypertension and recommend screening to be considered in those with Stage 2 hypertension. These updates reflect a growing recognition of the role of aldosterone dysregulation in disease pathophysiology and highlight the need for timely and effective hypertension management. In addition to novel treatment options, these updated recommendations present opportunities to gain a deep understanding of contemporary clinical practice, the prevalence of aldosterone dysregulation, and how these insights may drive initiatives for individualized and population level care. Effective hypertension management requires prioritizing early identification and establishing efficient treatment protocols. The overall REFOCUS-HTN Project consists of two parts: 1. REFOCUS-HTN: Retrospective data analysis. 2. SCALED (Study to Clinically Describe Aldosterone Dysregulation): Observational sub-study (SCALED) with primary data collection to supplement REFOCUS-HTN data. The SCALED sub-study will enroll a subset of \ 500 participants from the REFOCUS-HTN cohort for prospective data collection. Individuals with hypertension will be invited to participate in SCALED and will be provided informed consent. The clinical examination (Month 0) will consist of blood pressure and body composition measurements and blood and urine specimen collection. Blood and urine specimens collected will be collected on follow-up Months 2 and 6.
Interventions
OTHERobservational study
Participants are not assigned an intervention
Sponsors
Kaiser Permanente
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aldosterone Trajectories and Aldosterone Dysregulation | From enrollment to the end of the last lab visit six months post initial visit | Describe aldosterone trajectories and aldosterone dysregulation (including its prevalence) from baseline to six months; describe changes in aldosterone levels over time in the context of measures that are known to be related (e.g. renin, potassium etc.) and/or commonly assessed in routine clinical practice (e.g. blood pressure etc.). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical and Demographic Characteristics by Aldosterone Dysregulation Status | From enrollment to the end of the last lab visit six months post initial visit | Describe the clinical and demographic characteristics of individuals with hypertension, stratified by the presence or absence of aldosterone dysregulation. Outcome measures include baseline demographic characteristics, laboratory measurements, laboratory testing patterns, comorbidities, and medication use. |
Countries
United States
Contacts
CONTACTAnkeet S Bhatt, MD, MBA, ScM
CONTACTMirasol M Apostol-Largeteau, MPH
Outcome results
None listed