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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06868069
Acronym
HypoPHrail
Enrollment
220
Registered
2025-03-10
Start date
2024-07-15
Completion date
2027-07-15
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Old Age

Keywords

Blood pressure variability, Frailty

Brief 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.

Interventions

DIAGNOSTIC_TESTDiagnostic tests and questionnaires

Assessment of office blood pressure, orthostatic hypotension, 24-hour ambulatory blood pressure, frailty

Sponsors

Istituto Auxologico Italiano
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
75 Years to No maximum

Inclusion criteria

* Age ≥ 75 years * Diagnosis of hypertension according to the criteria of the European Society of Cardiology guidelines \[Williams 2018\] * Consent of the patient (or legal representative) to participate in the study

Exclusion criteria

* Refusal of the patient or his/her legal representative * Life expectancy of less than 6 months

Design outcomes

Primary

MeasureTime frameDescription
Incidence of adverse eventsAt 24 months of follow-upAdverse events at follow up (death, hospitalization, falls, emergency room admission for uncontrolled hypertension, major cardiovascular events)
Prevalence of hypotensive phenotypeAt baselineHypotensive 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)

Countries

Italy

Contacts

CONTACTAlessandro Croce, MD
a.croce@auxologico.it+3902619111
CONTACTLuca Grappiolo, Dr.
luca.grappiolo@auxologico.it+3902619111

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026