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NCT Number: NCT06868069

Study on Blood Pressure Variability and Frailty in the Older People

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)

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Key information

Age range

75 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Auxologico Italiano IRCCS

Milan, 20145, Italy

Location status: Recruiting

Location contact

Alessandro Croce, MD

CONTACT

[email protected]

+390261911

About this 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)

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diagnostic tests and questionnaires

Diagnostic Test

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

Primary outcomes

  1. 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)

  2. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Alessandro Croce, MD

CONTACT

[email protected]

+3902619111

Luca Grappiolo, Dr.

CONTACT

[email protected]

+3902619111 ext. 2894

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Registry information

Official study title

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

Acronym: HypoPHrail

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 10, 2025
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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