Study on Blood Pressure Variability and Frailty in the Older People

NCT06868069 | Recruiting

• 1 other identifier: 09C409
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

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)

Conditions

Hypertension; Old Age

Keywords

Blood pressure variability; Frailty

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events

  Adverse events at follow up (death, hospitalization, falls, emergency room admission for uncontrolled hypertension, major cardiovascular events)

  At 24 months of follow-up

• Prevalence of hypotensive phenotype

  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)

  At baseline

Study Arms (1)

Patients with hypertension, aged 75 years and older

Diagnostic Test: Diagnostic tests and questionnaires

Interventions

Diagnostic tests and questionnaires DIAGNOSTIC_TEST

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

Patients with hypertension, aged 75 years and older

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Elderly hypertensive patients who are enrolled at the Hypertension Centre of Istituto Auxologico italiano IRCCS

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Istituto Auxologico Italiano: lead

Study Sites (1)

Istituto Auxologico Italiano IRCCS

Milan, 20145, Italy

RECRUITING

MeSH Terms

Conditions

Hypertension; Frailty

Interventions

Diagnostic Tests, Routine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Alessandro Croce, MD

CONTACT

+3902619111; a.croce@auxologico.it

Luca Grappiolo, Dr.

CONTACT

+3902619111; luca.grappiolo@auxologico.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 10, 2025
• Study Start: July 15, 2024
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): July 15, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)