REFOCUS-HTN US-WEST: A Data Infrastructure to Characterize Individuals With Hypertension (REFOCUS-HTN)
REFOCUS-HTN US-WEST: a Data Infrastructure to Characterize Contemporary Individuals With Hypertension, Their Care, Health Outcomes, and Wellbeing
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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:
- REFOCUS-HTN: Retrospective data analysis.
- 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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Mirasol M Apostol-Largeteau, MPH
- Número de teléfono: 415-407-1754
- Correo electrónico: Mirasol.M.Apostol-Largeteau@kp.org
Copia de seguridad de contactos de estudio
- Nombre: Ankeet S Bhatt, MD, MBA, ScM
- Número de teléfono: 415-470-6571
- Correo electrónico: Ankeet.S.Bhatt@kp.org
Ubicaciones de estudio
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California
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Oakland, California, Estados Unidos, 94611
- Reclutamiento
- Kaiser Permanente Northern California
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Contacto:
- Tiffany Chen
- Número de teléfono: 925-789-5363
- Correo electrónico: tiffany.m.chen@kp.org
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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.
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Participants are not assigned an intervention
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Aldosterone Trajectories and Aldosterone Dysregulation
Periodo de tiempo: From enrollment to the end of the last lab visit six months post initial visit
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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.).
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From enrollment to the end of the last lab visit six months post initial visit
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Clinical and Demographic Characteristics by Aldosterone Dysregulation Status
Periodo de tiempo: From enrollment to the end of the last lab visit six months post initial visit
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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.
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From enrollment to the end of the last lab visit six months post initial visit
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Association between Patient Characteristics and Aldosterone Dysregulation
Periodo de tiempo: From enrollment to the end of the last lab visit six months post initial visit
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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
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2391390
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
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