Can Frailty Inform the Management of Hypertension in Older People?

Hypertension Clinical Trial

— Frail_BP  

Official title:

Is Frailty a Prognostic Factor for Relevant Outcomes in the Management of Hypertension in Older People, and is There Evidence That the Association of Blood Pressure and Outcomes is Different in the Context of Frailty?

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04662203
• Other study ID #: RTF107/0117
• Status: Active, not recruiting
• Start date: October 1, 2007
• Est. completion date: January 1, 2021

Study information

• Verified date: December 2020
• Source: University of Leeds
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study was to investigate in large scale routine primary care data whether frailty is a prognostic factor for relevant outcomes in the management of hypertension in older people and whether frailty causes effect modification of the association of blood pressure or blood pressure lowering treatment and outcomes in older people.

Description:

A retrospective cohort study used linked electronic health records from the Welsh Secure Anonymised Information Linkage (SAIL) databank. All patients had hypertension in the absence of established cardiovascular disease, and were over the age of 65 years in 2007. Systolic blood pressure and frailty, measured using the electronic frailty index were recorded. Patients were followed up for ten years. Time to event analysis measured first ever major adverse cardiovascular or cerebrovascular event (MACCE), all-cause mortality and injurious falls. Adjustment was made for established cardiovascular risk factors.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 145598
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Patient registered with a general practitioner contributing to SAIL database for at least 1 year

• Patient with blood pressure measured and recorded at any time after 1st January 2007 and before 1st January 2008, was used as the individual's index start date.

• Patient aged 65 years or older at the time of study entry.

Exclusion Criteria:

• Patient did not have a diagnosis of hypertension or did not have blood pressure meeting criteria for hypertension;

• Patient had an established history of cardiovascular disease (previous stroke, heart failure or myocardial infarction) prior to the start date.

Related Conditions & MeSH terms

• Frailty
• Hypertension

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University of Leeds	Dalhousie University, Swansea University, University of Oxford

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiovascular and cerebrovascular events	Myocardial infarction; stroke; new diagnosis of heart failure; cardiovascular death	10 years
Secondary	All-cause mortality	Death from any cause	10 years
Secondary	Injurious falls	Fall leading to fracture of bone and hospital admission	10 years