The Design of MOMENTUM: A Prospective Study of the Prevalence of Endogenous Hypercortisolism in Individuals With Resistant Hypertension

IF 3.5 2区 医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS
Jorge Plutzky , Richard J. Auchus , Jan N. Basile , Deepak L. Bhatt , Michael J. Bloch , Matthew A. Cavender , James W. Findling , Yehuda Handelsman , Silvio E. Inzucchi , Norman E. Lepor , Neha J. Pagidipati , Raymond R. Townsend , Matthew R. Weir , Iulia Cristina Tudor , Daniel Einhorn
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Abstract

Hypertension affects up to 50% of US adults and resistant hypertension (rHTN) occurs in 10-20% of cases. Endogenous hypercortisolism (eHC) may contribute to rHTN in some individuals, but the prevalence of eHC in individuals with rHTN is currently unknown. The CATALYST study assessing eHC prevalence in individuals with difficult-to-control type 2 diabetes, reported a 40% prevalence of eHC in participants with systolic blood pressure (BP) ≥135 mm Hg despite taking ≥3 BP medications (Handelsman Y, et al. WCIRDC 2024. Poster 0050). MOMENTUM is the first large, prospective study to examine the prevalence of eHC in people with rHTN in the US.
MOMENTUM is an observational study of ∼1,000 adults with rHTN using American Heart Association criteria. Key exclusion criteria are investigator-determined white coat hypertension, nonadherence to BP medications, and individuals in whom the dexamethasone suppression test is difficult to interpret. The primary endpoint is to assess the eHC prevalence in this population. Key secondary endpoints are to assess clinical and laboratory features associated with increased eHC risk. Hyperaldosteronism will also be screened for. Descriptive statistics will be used to characterize participants with and without eHC.
In conclusion, the MOMENTUM study, as designed and currently enrolling, will provide an estimate of eHC prevalence and its associated clinical characteristics in people with rHTN. (ClinicalTrials.gov Identifier: NCT06829537)
动量的设计:内源性高皮质醇血症在顽固性高血压患者患病率的前瞻性研究
高血压影响高达50%的美国成年人,顽固性高血压(rHTN)发生在10-20%的病例中。内源性高皮质醇血症(eHC)可能在某些个体中导致rHTN,但目前尚不清楚eHC在rHTN患者中的患病率。CATALYST研究评估了难以控制的2型糖尿病患者eHC的患病率,报告收缩压(BP)≥135 mm Hg的参与者,尽管服用了≥3bp的药物,eHC的患病率仍为40% (Handelsman Y, et al.)。WCIRDC 2024。海报0050)。MOMENTUM是美国第一个大型前瞻性研究,旨在调查rHTN患者中eHC的患病率。MOMENTUM是一项观察性研究,采用美国心脏协会标准,纳入约1000名患有rHTN的成人。主要的排除标准是研究者确定的白大衣高血压,不坚持降压药物,以及地塞米松抑制试验难以解释的个体。主要终点是评估该人群的eHC患病率。关键的次要终点是评估与eHC风险增加相关的临床和实验室特征。高醛固酮增多症也将被筛查。描述性统计将用于描述有和没有eHC的参与者。总之,根据设计和目前的招募情况,MOMENTUM研究将提供rHTN患者eHC患病率及其相关临床特征的估计。(ClinicalTrials.gov识别码:NCT06829537)
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来源期刊
American heart journal
American heart journal 医学-心血管系统
CiteScore
8.20
自引率
2.10%
发文量
214
审稿时长
38 days
期刊介绍: The American Heart Journal will consider for publication suitable articles on topics pertaining to the broad discipline of cardiovascular disease. Our goal is to provide the reader primary investigation, scholarly review, and opinion concerning the practice of cardiovascular medicine. We especially encourage submission of 3 types of reports that are not frequently seen in cardiovascular journals: negative clinical studies, reports on study designs, and studies involving the organization of medical care. The Journal does not accept individual case reports or original articles involving bench laboratory or animal research.
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