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RecruitingNCT06868069HypoPHrailUpdated Mar 30, 2026

Study on Blood Pressure Variability and Frailty in the Older People

An observational study in Hypertension and Old Age, sponsored by Istituto Auxologico Italiano. Recruiting at 1 site in Italy. Open to participants aged 75 Years and older. Per ClinicalTrials.gov, last updated 2026-03-30.

Sponsored by Istituto Auxologico Italiano · Observational

From the registry’s dates

  • Started Jul 2024; still recruiting 2 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
220
Ages
75 Years and older
Sex
All
01

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)

Read the 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.
02

Conditions studied

  • Hypertension
  • Old Age

Keywords

  • Blood pressure variability
  • Frailty
03

In context

Hypertension

6,687 studies on the registry are indexed under Hypertension; 964 are open to participants now.

This study's planned enrollment of 220 is close to the median of 210 across 1,358 observational studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Istituto Auxologico Italiano is the lead sponsor of 196 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
75 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

  • Refusal of the patient or his/her legal representative
  • Life expectancy of less than 6 months
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
220 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with hypertension, aged 75 years and older

    Diagnostic Test: Diagnostic tests and questionnaires

Interventions

  • Diagnostic testDiagnostic tests and questionnaires

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

06

What researchers measure

Primary outcomes

  1. Incidence of adverse events

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

    Time frame: At 24 months of follow-up

  2. 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)

    Time frame: At baseline

07

Study locations

1 of 1 sites recruiting
  • Istituto Auxologico Italiano IRCCS
    Milan, 20145, Italy
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06868069
Lead sponsor
Istituto Auxologico Italiano
Responsible party
Sponsor
First posted
Mar 10, 2025
Start date
Jul 15, 2024
Primary completion
Jul 15, 2027 (estimated)
Completion
Jul 15, 2027 (estimated)
Last update
Mar 30, 2026

Study contacts

Alessandro Croce, MD
Contact
a.croce@auxologico.it
+3902619111
Luca Grappiolo, Dr.
Contact
luca.grappiolo@auxologico.it
+3902619111 ext. 2894

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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