Manchester University NHS Foundation Trust
Manchester, Greater Manchester, m13 9wl, United Kingdom
Location status: Recruiting
NCT Number: NCT05955456
Heart failure represents a growing public health problem within the UK and particularly within the North West of England. A major challenge is that heart failure is currently diagnosed too late.
The researchers have previously developed a risk calculator that accurately identifies individuals at risk of heart failure admission or death before they have developed heart failure.
Most risk calculators are never implemented into clinical practice. The researchers will l perform a pilot study to evaluate the risk calculator within primary care in Greater Manchester.
Interested in participating?
Request Info50 year and older
All sexes
Observational
Manchester, Greater Manchester, m13 9wl, United Kingdom
Location status: Recruiting
The researchers have previously developed and externally validated a novel multimodal risk calculator that accurately identifies individuals at-risk of heart failure admission or death before they have developed heart failure. This risk calculator includes key co-morbidities, circulating biomarkers and cardiac magnetic resonance imaging (CMR) measurements of cardiac structure and function. It identifies those individuals at highest risk of developing heart failure and therefore those who may most benefit from targeted cardiometabolic therapeutics in the future.
The researchers will l perform a pilot study to evaluate the risk calculator within primary care in Greater Manchester. A qualitative and quantitative assessment of risk calculator uptake will be performed within local GP practices and primary care populations. The research team will determine how effectively they can recruit participants from socioeconomically deprived and ethnically diverse backgrounds. A preliminary analysis will be performed to determine risk calculator accuracy within a prospective primary care cohort, and dynamically refine the model aiming to improve performance. The study will also involve conducting an initial cost effectiveness analysis to determine the real-world economic impact of model implementation.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
No intervention is applied to participants. The risk calculator score is not released to the participants or care providers. Participants are followed up for risk calculator accuracy and recalibration.
Time frame: 5 years
Risk calculator will predict incident heart failure, first heart failure hospitalisation, cardiovascular death and all cause death
Time frame: 5 years
Number of participant identification sites, methods of participant identification, proportion of eligible participants contacted and recruited
Time frame: 5 years
Ability to recruit participants from socioeconomically deprived and ethnically diverse backgrounds within Greater Manchester
Time frame: 5 years
Examples include calibration slope, intercept and Harrell's C statistic
Time frame: 5 years
Assess variable inclusion and exclusion using stepwise model selection and Wald statistic
Time frame: 5 years
Mediation analysis to determine causative effects of hypothetical interventions
Time frame: 5 years
Examples include decision curve analysis
Manchester University NHS Foundation Trust
Other Gov
Detecting EARLY Heart Failure in Greater Manchester (EARLY-HF)
Acronym: EARLY-HF
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