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NCT05776394 Clinical Trial

Study on Hypertension and Frailty in the Older People

Frailty Clinical Trial

— HYPER-FRAIL  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05776394
Other study ID # 09C214
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 30, 2022
Est. completion date October 31, 2023

Study information
Verified date March 2023
Source Istituto Auxologico Italiano
Contact Alessandro IT Croce, MD
Phone 0261911
Email a.croce@auxologico.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date October 31, 2023
Est. primary completion date October 31, 2023
Accepts healthy volunteers
Gender All
Age group 75 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Ospedale San Luca Milano

Sponsors (1)
Lead Sponsor Collaborator
Istituto Auxologico Italiano

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Daytime systolic blood pressure variability Standard deviation of daytime systolic blood pressure At baseline
Secondary Nighttime systolic blood pressure variability Standard deviation of nighttime systolic blood pressure At baseline
Secondary 24h systolic blood pressure variability Standard deviation of 24h systolic blood pressure At baseline
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