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临床试验/NCT07535814
NCT07535814已完成不适用

VATAHTA-ACUTE Study

School of Medicine. National University of Cuyo1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
500
试验地点
1
主要终点
Length of hospital stay

研究概览

简要总结

Acute severe hypertension is a common and heterogeneous clinical condition associated with significant short-term morbidity and health care utilization. Despite its frequency, underlying pathophysiological mechanisms remain poorly characterized, particularly regarding the role of aldosterone dysregulation beyond classical primary aldosteronism.

The VATAHTA Acute Study is an observational cohort study designed to evaluate the association between aldosterone levels, renin profiles, and clinical outcomes in patients presenting with acute severe hypertension requiring hospital admission. The study aims to characterize a potential spectrum of aldosterone dysregulation and its relationship with short-term clinical severity, including length of hospital stay, target organ damage, and cardiovascular events.

By integrating clinical, biochemical, and outcome data, this study seeks to improve the understanding of pathophysiological phenotypes in acute severe hypertension and identify potential targets for risk stratification and future therapeutic strategies.

详细描述

Acute severe hypertension represents a frequent cause of emergency department visits and hospital admissions, yet its underlying biological heterogeneity is insufficiently understood. While classical secondary causes such as primary aldosteronism have been extensively studied, emerging evidence suggests that a broader continuum of aldosterone dysregulation may contribute to cardiovascular risk, even in the absence of overt endocrine hypertension.

The VATAHTA Acute Study is a multicenter observational cohort including adult patients admitted with acute severe hypertension, defined by markedly elevated blood pressure levels requiring hospital management. The study will systematically collect clinical characteristics, laboratory parameters-including plasma aldosterone, renin levels, and aldosterone-to-renin ratio-and treatment data at admission.

The primary objective is to evaluate the association between aldosterone levels and short-term clinical severity, assessed by length of hospital stay. Secondary objectives include the relationship between aldosterone profiles and target organ damage, biochemical alterations (such as potassium and renal function), and short-term cardiovascular outcomes, including major adverse cardiovascular events (MACE).

Multivariable analyses will be performed to determine whether aldosterone levels are independently associated with clinical severity after adjustment for relevant confounders, including blood pressure at admission, age, sex, renal function, and potassium levels. The study also aims to explore phenotypic patterns consistent with aldosterone dysregulation beyond classical definitions, potentially identifying clinically relevant subgroups.

This study is expected to provide novel insights into the pathophysiology of acute severe hypertension and contribute to improved risk stratification and personalized management strategies.

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

入选标准

  • Adults aged ≥18 years Hospital admission due to acute severe hypertension, defined as systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥120 mmHg requiring in-hospital management Availability of plasma aldosterone and renin measurements at hospital admission or within the first 24 hours Availability of key clinical and laboratory data, including blood pressure, renal function, and serum potassium levels

排除标准

  • Pregnancy or hypertensive disorders of pregnancy Known secondary hypertension due to endocrine causes other than suspected aldosterone dysregulation (e.g., pheochromocytoma, Cushing syndrome) Patients receiving chronic dialysis Severe acute conditions likely to independently determine short-term outcomes (e.g., septic shock, major trauma) Missing key data required for primary outcome assessment (length of hospital stay) Prior inclusion in the study cohort

结局指标

主要结局

Length of hospital stay

时间窗: rom hospital admission to discharge (index hospitalization), an average of 36 months

Length of hospital stay (LOS), measured in days, defined as the time from hospital admission to discharge, will be used as a marker of short-term clinical severity. The association between plasma aldosterone levels and LOS will be evaluated using multivariable models adjusted for relevant clinical and biochemical confounders.

次要结局

未报告次要终点

研究者

发起方
School of Medicine. National University of Cuyo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicolas Federico Renna

Associate Professor of Phisiopathology. School of Medicine. National University of Cuyo

School of Medicine. National University of Cuyo

研究点 (1)

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