Detecting EARLY Heart Failure in Greater Manchester

Phase

N/A

Condition

Chest Pain

Congestive Heart Failure

Heart Failure

Treatment

No intervention

Clinical Study ID

NCT05955456

B01899

Ages > 50
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Written informed consent
Aged 50 and over
Two or more of the following conditions: type 2 diabetes, chronic obstructivepulmonary disease, ischaemic heart disease, atrial fibrillation, hypertension,chronic kidney disease stage 3, body mass index ≥ 30 kg/m2

Exclusion

Exclusion Criteria:

Established diagnosis of one or more of the following: heart failure,cardiomyopathy, moderate or severe valvular heart disease, congenital heart disease,heart transplant, idiopathic, heritable or drug-induced pulmonary arterialhypertension, any medical condition, which in the opinion of the Investigator, mayplace the patient at higher risk from his/her participation in the study, or islikely to prevent the patient from complying with the requirements of the study orcompleting the study.
Contraindication to cardiovascular magnetic resonance (CMR) scanning, includingpacemaker, defibrillator, intraocular metal, intracranial aneurysm clips, severeclaustrophobia, estimated glomerular filtration rate < 30 ml/min/1.73m2, previoussevere allergic reaction or anaphylaxis to gadolinium-based contrast agent,pregnancy or breastfeeding.

Study Design

No intervention

October 09, 2023

September 01, 2030

Study 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.

Connect with a study center

Manchester University NHS Foundation Trust
Manchester, Greater Manchester m13 9wl
United Kingdom
Site Not Available
Manchester University NHS Foundation Trust
Manchester 2643123, Greater Manchester m13 9wl
United Kingdom
Active - Recruiting

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