An observational study in Hypertension, Aldosterone Disorder and Cardiovascular Disease (CVD), sponsored by Kaiser Permanente. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Kaiser Permanente · Observational
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.
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:
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.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 500 is above the median of 350 across 1,163 observational studies indexed under Hypertension.
Browse Hypertension studies →Kaiser Permanente is the lead sponsor of 393 studies on the registry; 43 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
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REFOCUS-HTN and SCALED will be conducted at KPNC. The KPNC Division of Research (DOR) will serve as the clinical and data coordinating center for all REFOCUS-HTN activities.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Additional Eligibility Criteria for SCALED:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The SCALED Cohort will include \~500 participants from the REFOCUS-HTN Cohort who are KPNC health plan members aged 18 years or older with established hypertension diagnosed within the past 18 months prior to screening.
Other: observational study
Participants are not assigned an intervention
Aldosterone Trajectories and Aldosterone Dysregulation
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.).
Time frame: From enrollment to the end of the last lab visit six months post initial visit
Clinical and Demographic Characteristics by Aldosterone Dysregulation Status
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.
Time frame: From enrollment to the end of the last lab visit six months post initial visit
Proportion of Patients with Aldosterone Dysregulation by Patient Characteristics
Identify patient and clinical characteristics associated with aldosterone dysregulation among individuals with hypertension. The outcome measure will be the proportion of patients with aldosterone dysregulation (overt or subclinical), defined according to the criteria established for the primary objective of the SCALED study. The proportion of patients with aldosterone dysregulation will be evaluated according to demographic characteristics, clinical history, laboratory values, and medication use. Note: These analyses are contingent upon the results of a feasibility assessment based on data available from the SCALED study.
Time frame: From enrollment to the end of the last lab visit six months post initial visit
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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