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
• Status: Recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Frailty
• High Blood Pressure
• Hypertension

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