Study on Blood Pressure Variability and Frailty in the Older People

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-15

Study Completion Date

2027-07-15

Brief Summary

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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)

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Detailed Description

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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

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Hypertension Old Age

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with hypertension, aged 75 years and older

Diagnostic tests and questionnaires

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Diagnostic tests and questionnaires

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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