Study on Blood Pressure Variability and Frailty in the Older People

Recruiting

• Conditions: Hypertension; Old Age

• Registration Number: NCT06868069
• Lead Sponsor: Istituto Auxologico Italiano

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.

Study Timeline

• Study Start: 2024-07-15
• Status Verified: 2025-03
• Study First Submitted: 2025-03-05
• Study First Submitted QC: 2025-03-05
• Last Update Submitted: 2025-03-05
• Study First Posted: 2025-03-10
• Last Update Posted: 2025-03-10
• Primary Completion: 2027-07-15
• Study Completion: 2027-07-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	At 24 months of follow-up	Adverse events at follow up (death, hospitalization, falls, emergency room admission for uncontrolled hypertension, major cardiovascular events)
Prevalence of hypotensive phenotype	At baseline	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)

Trial Locations

Locations (1)

Istituto Auxologico Italiano IRCCS; 🇮🇹 Milan, Italy