Recruiting

Observational Study

Sponsor:

Kaiser Permanente

Code:

NCT07780500

Conditions

Hypertension

Aldosterone Disorder

Cardiovascular Disease (CVD)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

observational study

Study Details

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.

Conditions

Hypertension

Aldosterone Disorder

Cardiovascular Disease (CVD)

Study ID

NCT07780500

Start date

Aug 20, 2026

Status verified date

Jul, 2026

Completion date

Mar, 2029

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

SCALED Cohort

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.

Interventions

observational study

Participants are not assigned an intervention

Primary outcome measure

  • Aldosterone Trajectories and Aldosterone Dysregulation [ Time Frame: From enrollment to the end of the last lab visit six months post initial visit ]

Central Contacts and Locations

Central contacts

Ankeet S Bhatt, MD, MBA, ScM

415-470-6571Ankeet.S.Bhatt@kp.org

Mirasol M Apostol-Largeteau, MPH

415-407-1754Mirasol.M.Apostol-Largeteau@kp.org

Locations

Kaiser Permanente Northern California

Recruiting

Oakland, California, United States, 94611

Contacts

More Information

Sponsor

Kaiser Permanente

Last update posted

Aug 21, 2026

Last verified

Jul, 2026

Keywords

  • Hypertension
  • Aldosterone
  • aldosterone dysregulation
  • aldosterone disorder
  • cardiovascular disease (CVD)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kaiser Permanente on 2026-08-21.