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Clinical Trials/NCT04662203
NCT04662203
Unknown
Not Applicable

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?

University of Leeds0 sites145,598 target enrollmentOctober 1, 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
University of Leeds
Enrollment
145598
Primary Endpoint
Major adverse cardiovascular and cerebrovascular events
Last Updated
5 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
October 1, 2007
End Date
January 1, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Oliver Todd

Dunhill Medical Trust doctoral research fellow

University of Leeds

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Major adverse cardiovascular and cerebrovascular events

Time Frame: 10 years

Myocardial infarction; stroke; new diagnosis of heart failure; cardiovascular death

Secondary Outcomes

  • All-cause mortality(10 years)
  • Injurious falls(10 years)

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