Actively Recruiting

Age: 75Years +
All Genders
ID06868069

Study on Blood Pressure Variability and Frailty in Older Adults with Hypertension: the HypoPHrail Study

Led by Istituto Auxologico Italiano · Updated on 2026-03-30

220

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to study blood pressure variability and frailty in older adults who have hypertension. It focuses on whether a hypotensive phenotype, defined by specific low daytime systolic blood pressure episodes detected through ambulatory blood pressure monitoring, is linked to adverse events such as death, hospitalization, falls, uncontrolled hypertension emergencies, or major cardiovascular events. This observational, prospective, single-center study is conducted by Istituto Auxologico Italiano and is non-profit in nature. Participants are assessed using diagnostic tests and questionnaires that measure office blood pressure, orthostatic hypotension, 24-hour ambulatory blood pressure, and frailty using several assessment tools. The study also examines the relationship between home blood pressure variability and frailty, as well as short-term blood pressure variability and adverse events. The prevalence of the hypotensive phenotype in hypertensive individuals according to frailty status is also determined. During the study, participants will undergo blood pressure monitoring and frailty assessments. Researchers will track the incidence of adverse events over a 24-month follow-up period and assess the prevalence of the hypotensive phenotype at the start of the study. The total participation duration includes baseline assessments and follow-up to observe outcomes related to blood pressure variability and frailty in older adults with hypertension.

CONDITIONS

Brief Title

Study on Blood Pressure Variability and Frailty in the Older People

Who Can Participate

Age: 75Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 63 75 years
  • Diagnosis of hypertension according to European Society of Cardiology guidelines
  • Consent of the patient or legal representative to participate in the study
Not Eligible

You will not qualify if you...

  • Refusal to participate by the patient or legal representative
  • Life expectancy less than 6 months

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Baseline

Participants undergo diagnostic tests including assessment of office blood pressure, orthostatic hypotension, 24-hour ambulatory blood pressure monitoring, and frailty assessment using questionnaires.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 24 months

Participants are monitored for adverse events such as hospitalization, falls, and cardiovascular events over the follow-up period.

Periodic follow-up visits for up to 24 months

Trial Site Locations

Total: 1 location

1

Istituto Auxologico Italiano IRCCS

Milan, Italy, 20145

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Research Team

A

Alessandro Croce, MD

L

Luca Grappiolo, Dr.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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