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Clinical Trials/NCT05756127
NCT05756127Active, not recruitingNot Applicable

Predicting Incident Heart Failure from Population-based Nationwide Electronic Health Records: Protocol for a Model Development and Validation Study

University of Leeds1 site in 1 country14,000 target enrollmentStarted: April 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
14,000
Locations
1
Primary Endpoint
To develop and validate a for predicting the risk of new onset HF

Study Overview

Brief Summary

Heart failure (HF) is increasingly common and associated with excess morbidity, mortality and healthcare costs. New medications are now available which can alter the disease trajectory and reduce clinical events. However, many cases of HF remain undetected until presentation with more advanced symptoms, often requiring hospitalisation. Earlier identification and treatment of HF could reduce downstream healthcare impact, but predicting HF incidence is challenging due to the complexity and varying course of HF. The investigators will use routinely collected hospital-linked primary care data and focus on the use of artificial intelligence methods to develop and validate a prediction model for incident HF. Using clinical factors readily accessible in primary care, the investigators will provide a method for the identification of individuals in the community who are at risk of HF, as well as when incident HF will occur in those at risk, thus accelerating research assessing technologies for the improvement of risk prediction, and the targeting of high-risk individuals for preventive measures and screening.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Other

Eligibility Criteria

Ages
16 Years to 120 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Aged 16 years and older
  • No history of heart failure
  • A minimum of one year follow up

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

To develop and validate a for predicting the risk of new onset HF

Time Frame: Between 2nd Jan 1998 and 28 Feb 2022

Predictive factors will be identified using Read codes (diagnoses), All variables will be considered as potential predictors, and may include: 1. sociodemographic variables: age, sex, ethnicity, index of multiple deprivation; 2. lifestyle factors (e.g. smoking status, alcohol consumption);

To identify and quantify the magnitude of predictors of new onset HF

Time Frame: Between 2nd Jan 1998 and 28 Feb 2022

The proposed model can extract informative risk factors from EHR data. Specifically we will fit multivariable Cox proportional hazard models with backwards elimination approach to retain predictors of incident HF within each prediction window.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr Christopher Gale

Professor of Cardiovascular Medicine

University of Leeds

Study Sites (1)

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