Understanding aldosterone in hypertension among Kaiser Permanente members

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

REFOCUS-HTN US-WEST is an observational program combining retrospective data and a prospective sub-study called SCALED to describe aldosterone dysregulation in hypertension. The SCALED sub-study enrolls about 500 adults from the REFOCUS-HTN cohort and collects primary data at baseline to explore the role of aldosterone in resistant and stage 2 hypertension. The project aligns with updated guidelines that emphasize screening for primary aldosteronism and aims to inform individualized and population-level hypertension management. Data are drawn from electronic health records and new clinical assessments to characterize prevalence, clinical features, and potential treatment implications. The lead sponsor is Kaiser Permanente with collaboration from AstraZeneca, focusing on the Northern California region.

Why it matters

Who can join: the full rules

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 it's running

• Kaiser Permanente Northern California
  Oakland, California, United States Recruiting

Study contacts

• Study coordinator: Ankeet S Bhatt, MD, MBA, ScM
• Email: Ankeet.S.Bhatt@kp.org
• Phone: 415-470-6571

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.