Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05955456

Detecting EARLY Heart Failure in Greater Manchester

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Manchester University NHS Foundation Trust

Manchester, Greater Manchester, m13 9wl, United Kingdom

Location status: Recruiting

Location contact

Nicholas Black, BM BCh

CONTACT

[email protected]

0161 291 4075

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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 arterial hypertension, any medical condition, which in the opinion of the Investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.
  • Contraindication to cardiovascular magnetic resonance (CMR) scanning, including pacemaker, defibrillator, intraocular metal, intracranial aneurysm clips, severe claustrophobia, estimated glomerular filtration rate < 30 ml/min/1.73m2, previous severe allergic reaction or anaphylaxis to gadolinium-based contrast agent, pregnancy or breastfeeding.

Treatment and study plan

No intervention

Other

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.

Primary outcomes

  1. Preliminary measures of risk calculator validation and accuracy in Greater Manchester

    Time frame: 5 years

    Risk calculator will predict incident heart failure, first heart failure hospitalisation, cardiovascular death and all cause death

Secondary outcomes

  1. Qualitative measures of primary care uptake and engagement

    Time frame: 5 years

    Number of participant identification sites, methods of participant identification, proportion of eligible participants contacted and recruited

  2. Proportion of participants recruited from socioeconomically deprived and ethnically diverse backgrounds

    Time frame: 5 years

    Ability to recruit participants from socioeconomically deprived and ethnically diverse backgrounds within Greater Manchester

  3. Measures of prognostic model calibration and discrimination in a primary care population

    Time frame: 5 years

    Examples include calibration slope, intercept and Harrell's C statistic

  4. Measures of prognostic model optimisation and accuracy with iterative variable inclusion or exclusion

    Time frame: 5 years

    Assess variable inclusion and exclusion using stepwise model selection and Wald statistic

  5. Causal statistical analysis to determine effect of hypothetical interventions

    Time frame: 5 years

    Mediation analysis to determine causative effects of hypothetical interventions

  6. Measures of cost effectiveness of the model in Greater Manchester

    Time frame: 5 years

    Examples include decision curve analysis

Sponsors and collaborators

Lead sponsor

Manchester University NHS Foundation Trust

Other Gov

Registry information

Official study title

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

Acronym: EARLY-HF

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Jul 21, 2023
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.