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

14. august 2026 opdateret af: Kaiser Permanente

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

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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:

  1. REFOCUS-HTN: Retrospective data analysis.
  2. SCALED (Study to Clinically Describe Aldosterone Dysregulation): Observational sub-study (SCALED) with primary data collection to supplement REFOCUS-HTN data.

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

500

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • California
      • Oakland, California, Forenede Stater, 94611
        • Rekruttering
        • Kaiser Permanente Northern California
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Andet: observational study
Participants are not assigned an intervention

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Aldosterone Trajectories and Aldosterone Dysregulation
Tidsramme: 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.).
From enrollment to the end of the last lab visit six months post initial visit

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Clinical and Demographic Characteristics by Aldosterone Dysregulation Status
Tidsramme: From enrollment to the end of the last lab visit six months post initial visit
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.
From enrollment to the end of the last lab visit six months post initial visit

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Association between Patient Characteristics and Aldosterone Dysregulation
Tidsramme: From enrollment to the end of the last lab visit six months post initial visit

Identify patient and clinical characteristics associated with aldosterone dysregulation among individuals with hypertension.

The outcome measure will be the association between patient characteristics and aldosterone dysregulation, quantified using odds ratios (or other appropriate effect estimates) for demographic characteristics, clinical history, laboratory values, and medication use. Aldosterone dysregulation (overt or subclinical) will be defined according to the criteria established for the primary objective of the SCALED study.

Note: These analyses are contingent upon the results of a feasibility assessment based on data available from the SCALED study.
From enrollment to the end of the last lab visit six months post initial visit

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Kaiser Permanente

Samarbejdspartnere

AstraZeneca

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

20. august 2026

Primær færdiggørelse (Anslået)

1. marts 2028

Studieafslutning (Anslået)

1. marts 2029

Datoer for studieregistrering

Først indsendt

14. august 2026

Først indsendt, der opfyldte QC-kriterier

14. august 2026

Først opslået (Faktiske)

21. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

21. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. august 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2391390

Plan for individuelle deltagerdata (IPD)

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