Clinical Trials Directory

Trials / Recruiting

RecruitingNCT05955456

Detecting EARLY Heart Failure in Greater Manchester

Detecting EARLY Heart Failure in Greater Manchester (EARLY-HF)

Status
Recruiting
Phase
Study type
Observational
Enrollment
600 (estimated)
Sponsor
Manchester University NHS Foundation Trust · Other Government
Sex
All
Age
50 Years
Healthy volunteers

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
OTHERNo interventionNo 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.

Timeline

Start date
2023-10-09
Primary completion
2030-09-01
Completion
2030-09-01
First posted
2023-07-21
Last updated
2025-10-01

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT05955456. Inclusion in this directory is not an endorsement.

Detecting EARLY Heart Failure in Greater Manchester (NCT05955456) · Clinical Trials Directory