NCT06868069

Study on Blood Pressure Variability and Frailty in the Older People

Study on Blood Pressure Variability and Frailty in the Older People: the HypoPHrail Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 220 (estimated)
• Sponsor: Istituto Auxologico Italiano · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: —

Summary

Observational prospective single-center, non-profit study. Primary objective of the study: To determine if the hypotensive phenotype, defined as one episode of daytime systolic blood pressure (SBP) \<90 mmHg (or two episodes of daytime SBP \<90 mmHg, if mean 24 h SBP is \<125 mmHg) detected at Ambulatory Blood Pressure Monitoring (ABPM) is associated with adverse events at follow up (death, hospitalization, falls, emergency room admission for uncontrolled hypertension, major cardiovascular events)

Detailed description

Observational prospective single-center, non-profit study. Primary objective of the study: To determine if the hypotensive phenotype, defined as one episode of daytime systolic blood pressure (SBP) \<90 mmHg (or two episodes of daytime SBP \<90 mmHg, if mean 24 h SBP is \<125 mmHg) detected at Ambulatory Blood Pressure Monitoring (ABPM) is associated with adverse events at follow up (death, hospitalization, falls, emergency room admission for uncontrolled hypertension, major cardiovascular events) Secondary objectives of the study: * To examine the association between home Blood Pressure Variability (BPV) and frailty, assessed using various tools for assessing frailty * To examine the association between short term BPV and adverse events at follow up (death, hospitalization, falls, emergency room admission for uncontrolled hypertension, major cardiovascular events) * To determine the prevalence of hypotensive phenotype according to frailty status in hypertensive individuals.

Conditions

• Hypertension
• Old Age

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Diagnostic tests and questionnaires	Assessment of office blood pressure, orthostatic hypotension, 24-hour ambulatory blood pressure, frailty

Timeline

• Start date: 2024-07-15
• Primary completion: 2027-07-15
• Completion: 2027-07-15
• First posted: 2025-03-10
• Last updated: 2026-03-30

Locations

1 site across 1 country: Italy