Study on Blood Pressure Variability and Frailty in the Older People

Last updated: March 5, 2025
Sponsor: Istituto Auxologico Italiano
Overall Status: Active - Recruiting

Phase

N/A

Condition

Williams Syndrome

Stress

Circulation Disorders

Treatment

Diagnostic tests and questionnaires

Clinical Study ID

NCT06868069
09C409
  • Ages > 75
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥ 75 years

  • Diagnosis of hypertension according to the criteria of the European Society ofCardiology guidelines [Williams 2018]

  • Consent of the patient (or legal representative) to participate in the study

Exclusion

Exclusion Criteria:

  • Refusal of the patient or his/her legal representative

  • Life expectancy of less than 6 months

Study Design

Total Participants: 220
Treatment Group(s): 1
Primary Treatment: Diagnostic tests and questionnaires
Phase:
Study Start date:
July 15, 2024
Estimated Completion Date:
July 15, 2027

Study 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.

Connect with a study center

  • Istituto Auxologico Italiano IRCCS

    Milan, 20145
    Italy

    Active - Recruiting

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