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

2026年8月14日 更新者：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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

观察性的

注册 (估计的)

500

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 美国
    • California
      • Oakland、California、美国、94611
        • 招聘中
        • Kaiser Permanente Northern California
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

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.

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
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.
其他：observational study
Participants are not assigned an intervention

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Aldosterone Trajectories and Aldosterone Dysregulation
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Clinical and Demographic Characteristics by Aldosterone Dysregulation Status
大体时间：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

其他结果措施

结果测量
措施说明
大体时间
Association between Patient Characteristics and Aldosterone Dysregulation
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Kaiser Permanente

合作者

AstraZeneca

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月20日

初级完成 (估计的)

2028年3月1日

研究完成 (估计的)

2029年3月1日

研究注册日期

首次提交

2026年8月14日

首先提交符合 QC 标准的

2026年8月14日

首次发布 (实际的)

2026年8月21日

研究记录更新

最后更新发布 (实际的)

2026年8月21日

上次提交的符合 QC 标准的更新

2026年8月14日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2391390

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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