REFOCUS-HTN US-WEST: a Data Infrastructure to Characterize Contemporary Individuals With Hypertension, Their Care, Health Outcomes, and Wellbeing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Aldosterone Trajectories and Aldosterone Dysregulation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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,
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: observational study (Other)
结局指标
主要结局
Aldosterone Trajectories and Aldosterone Dysregulation
时间窗: 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.).
次要结局
- Clinical and Demographic Characteristics by Aldosterone Dysregulation Status(From enrollment to the end of the last lab visit six months post initial visit)