NCT07780500 · Kaiser Permanente
REFOCUS-HTN US-WEST: A Data Infrastructure to Characterize Individuals With Hypertension
(REFOCUS-HTN)
What this study is about
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 group of participants study that will enroll from REFOCUS-HTN group of participants for forward-looking data collection.
View original scientific description
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.
Interventions
OTHER
observational study
Participants are not assigned an intervention
Primary outcome measures
Aldosterone Trajectories and Aldosterone Dysregulation
Time frame: 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.).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Oakland, California
Collaborators
AstraZeneca
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 21, 2026 · Source of record for eligibility and locations