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

March 25, 2026 updated by: Istituto Auxologico Italiano

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

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Milan, Italy, 20145
        • Recruiting
        • Istituto Auxologico Italiano IRCCS
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with hypertension, aged 75 years and older
Diagnostic test: Diagnostic tests and questionnaires
Assessment of office blood pressure, orthostatic hypotension, 24-hour ambulatory blood pressure, frailty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: At 24 months of follow-up
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
Time Frame: 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)
At baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Auxologico Italiano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2024

Primary Completion (Estimated)

July 15, 2027

Study Completion (Estimated)

July 15, 2027

Study Registration Dates

First Submitted

March 5, 2025

First Submitted That Met QC Criteria

March 5, 2025

First Posted (Actual)

March 10, 2025

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09C409

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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