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HYPER-FRAIL: Study on Hypertension and Frailty in the Older People

Sponsor
Istituto Auxologico Italiano (Other)
Overall Status
Recruiting
CT.gov ID
NCT05776394
Collaborator
(none)
150
Enrollment
1
Location
17.1
Anticipated Duration (Months)
8.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To estimate the linear association between daytime systolic blood pressure variability evaluated as standard deviation (SD) and frailty evaluated as Frailty index according to the Rockwood's accumulation of deficits model

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Study on Hypertension and Frailty in the Older People: the HYPER-FRAIL Study
    Actual Study Start Date :
    May 30, 2022
    Anticipated Primary Completion Date :
    Oct 31, 2023
    Anticipated Study Completion Date :
    Oct 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Daytime systolic blood pressure variability [At baseline]

      Standard deviation of daytime systolic blood pressure

    Secondary Outcome Measures

    1. Nighttime systolic blood pressure variability [At baseline]

      Standard deviation of nighttime systolic blood pressure

    2. 24h systolic blood pressure variability [At baseline]

      Standard deviation of 24h systolic blood pressure

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    75 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • Diagnosis of hypertension according to the criteria of the European Society of Cardiology guidelines

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ospedale San Luca Milano Italy 28145

    Sponsors and Collaborators

    • Istituto Auxologico Italiano

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Istituto Auxologico Italiano
    ClinicalTrials.gov Identifier:
    NCT05776394
    Other Study ID Numbers:
    • 09C214
    First Posted:
    Mar 20, 2023
    Last Update Posted:
    Mar 20, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hypertension
    Frailty

    Study Results

    No Results Posted as of Mar 20, 2023