Detecting early heart failure in Greater Manchester
Detecting EARLY Heart Failure in Greater Manchester (EARLY-HF)
Manchester University NHS Foundation Trust · NCT05955456
This study is testing a new tool to see if it can help doctors in Greater Manchester find people at risk of heart failure before it happens, especially those from different backgrounds.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Manchester University NHS Foundation Trust (other gov) |
| Locations | 1 site (Manchester, Greater Manchester) |
| Trial ID | NCT05955456 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate a novel multimodal risk calculator designed to identify individuals at risk of heart failure before its onset. The risk calculator incorporates key co-morbidities, circulating biomarkers, and cardiac magnetic resonance imaging (CMR) measurements to pinpoint those at highest risk. The pilot study will assess the uptake of this tool within primary care settings in Greater Manchester, focusing on recruiting participants from diverse and socioeconomically deprived backgrounds. Additionally, a preliminary analysis will evaluate the accuracy of the risk calculator and its potential cost-effectiveness in real-world applications.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 50 and over with two or more specified co-morbid conditions.
Not a fit: Patients with an established diagnosis of heart failure or other significant cardiac conditions will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection and intervention for heart failure, potentially improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using risk calculators for early detection of heart failure, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Manchester, Greater Manchester
- Manchester University NHS Foundation Trust — Manchester, Greater Manchester, United Kingdom (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure