Study on Blood Pressure Variability and Frailty in the Older People
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Diagnostic tests and questionnaires.
- Who it may be relevant to
- Registry conditions: Hypertension, Old Age. Basic parameters: from 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Study on Blood Pressure Variability and Frailty in the Older People: the HypoPHrail Study
Overview
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 test Diagnostic tests and questionnaires
Assessment of office blood pressure, orthostatic hypotension, 24-hour ambulatory blood pressure, frailty
Primary outcome measures
- Incidence of adverse events [Time frame: At 24 months of follow-up]
- Prevalence of hypotensive phenotype [Time frame: At baseline]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Istituto Auxologico Italiano IRCCS — Milan
Identifiers
NCT: NCT06868069 · 09C409