Aldosterone Identifies a High-Risk Recurrent Phenotype in Severe Hypertension (VATAHTA-ACUTE)

VATAHTA-ACUTE Study

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.

Study Overview

• Status: Completed
• Conditions: Acute Severe Hypertension

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.

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• Argentina
  • Mendoza Province
    • Godoy Cruz, Mendoza Province, Argentina, 5501
      • Laura Grazini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients admitted to hospital due to acute severe hypertension, identified from institutional databases. The study population includes individuals with available biochemical assessment of the renin-angiotensin-aldosterone system at admission, allowing evaluation of aldosterone-related pathophysiological phenotypes and their association with short-term clinical outcomes.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	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.	rom hospital admission to discharge (index hospitalization), an average of 36 months

Collaborators and Investigators

• Sponsor: School of Medicine. National University of Cuyo
• Collaborators: Hospiral Español de Mendoza

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): December 20, 2025
• Study Completion (Actual): April 1, 2026

Study Registration Dates

• First Submitted: April 5, 2026
• First Submitted That Met QC Criteria: April 14, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Aldosterone; Acute Severe Hypertension; Cardiovascular Risk
• Other Study ID Numbers: VATAHTA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No