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REFOCUS-HTN US-WEST: A Data Infrastructure to Characterize Individuals With Hypertension

REFOCUS-HTN US-WEST: a Data Infrastructure to Characterize Contemporary Individuals With Hypertension, Their Care, Health Outcomes, and Wellbeing

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how a hormone called aldosterone may help cause high blood pressure. The SCALED part will follow adults from the REFOCUS-HTN group who were diagnosed with high blood pressure in the past 18 months.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older and part of the REFOCUS-HTN group.
  • Have high blood pressure recorded in KPNC electronic health records from January 2012 through March 31, 2029. Meet at least one of the next three conditions.
  • Have at least one high blood pressure diagnosis at a clinic visit, not an emergency room visit.
  • Have a top blood pressure number of 130 or higher at two clinic checks in a row, at least 90 days apart.
  • Have a bottom blood pressure number of 80 or higher at two clinic checks in a row, at least 90 days apart.
  • For SCALED, have been diagnosed with high blood pressure within 18 months before screening.
  • For SCALED, have health plan coverage without a break for at least 6 months before the first visit.

Who can't join

  • Have high blood pressure known to be caused by drugs, alcohol, or problems with blood vessels that supply the kidneys.
  • Had weight-loss surgery or a prescription for a GLP-1 medicine in the past 12 months.
  • Used an aldosterone synthase inhibitor or a mineralocorticoid receptor antagonist in the past 12 weeks. These medicines reduce aldosterone production or block its effects.
  • Have a latest estimated kidney filtering rate (eGFR) below 45 mL/min/1.73 m² at screening.
  • Have had a kidney transplant.
  • Are getting dialysis, a treatment that filters the blood.
  • Are currently in another trial testing a treatment for heart or blood vessel disease or high blood pressure.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

CA