Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-25 @ 9:23 PM
Study NCT ID:
NCT05955456
Status:
RECRUITING
Last Update Posted:
2025-10-01
First Post:
2023-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Detecting EARLY Heart Failure in Greater Manchester
Sponsor:
Manchester University NHS Foundation Trust
Organization:
Study Overview
Official Title:
Detecting EARLY Heart Failure in Greater Manchester (EARLY-HF)
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EARLY-HF
Brief 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.
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: