NCT05776394

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 30, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 20, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

March 20, 2023

Status Verified

March 1, 2023

Enrollment Period

1.4 years

First QC Date

March 8, 2023

Last Update Submit

March 8, 2023

Conditions

FrailtyHigh Blood Pressure

Outcome Measures

Primary Outcomes (1)

  • Daytime systolic blood pressure variability

    Standard deviation of daytime systolic blood pressure

    At baseline

Secondary Outcomes (2)

  • Nighttime systolic blood pressure variability

    At baseline

  • 24h systolic blood pressure variability

    At baseline

Eligibility Criteria

Age75 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elderly patients

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale San Luca

Milan, 28145, Italy

RECRUITING

MeSH Terms

Conditions

FrailtyHypertension

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsVascular DiseasesCardiovascular Diseases

Central Study Contacts

Alessandro IT Croce, MD

CONTACT

0261911a.croce@auxologico.it

Martino IT Pengo, PhD

CONTACT

m.pengo@auxologico.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2023

First Posted

March 20, 2023

Study Start

May 30, 2022

Primary Completion

October 31, 2023

Study Completion

October 31, 2023

Last Updated

March 20, 2023

Record last verified: 2023-03

Locations

IT(1)