NCT07535814

Aldosterone Identifies a High-Risk Recurrent Phenotype in Severe Hypertension

VATAHTA-ACUTE Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 500 (actual)
• Sponsor: School of Medicine. National University of Cuyo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Acute Severe Hypertension

Timeline

• Start date: 2022-03-01
• Primary completion: 2025-12-20
• Completion: 2026-04-01
• First posted: 2026-04-17
• Last updated: 2026-04-17

Locations

1 site across 1 country: Argentina