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

Istituto Auxologico Italiano

Status: Enrolling

Conditions: Hypertension; Old Age

Treatments: Diagnostic Test: Diagnostic tests and questionnaires

Study type: Observational

Funder types: Other

Identifiers

NCT06868069

09C409

Details and patient eligibility

About

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)

Full 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.

Enrollment: 220 estimated patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

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

Trial design

220 participants in 1 patient group

Patients with hypertension, aged 75 years and older

Treatment:

Diagnostic Test: Diagnostic tests and questionnaires