Heart Failure Clinical Trial
— EARLY-HFOfficial title:
Detecting EARLY Heart Failure in Greater Manchester (EARLY-HF)
NCT number | NCT05955456 |
Other study ID # | B01899 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 9, 2023 |
Est. completion date | September 1, 2030 |
Verified date | October 2023 |
Source | Manchester University NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Recruiting |
Enrollment | 600 |
Est. completion date | September 1, 2030 |
Est. primary completion date | September 1, 2030 |
Accepts healthy volunteers | |
Gender | All |
Age group | 50 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Manchester University NHS Foundation Trust | Manchester | Greater Manchester |
Lead Sponsor | Collaborator |
---|---|
Manchester University NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Preliminary measures of risk calculator validation and accuracy in Greater Manchester | Risk calculator will predict incident heart failure, first heart failure hospitalisation, cardiovascular death and all cause death | 5 years | |
Secondary | Qualitative measures of primary care uptake and engagement | Number of participant identification sites, methods of participant identification, proportion of eligible participants contacted and recruited | 5 years | |
Secondary | Proportion of participants recruited from socioeconomically deprived and ethnically diverse backgrounds | Ability to recruit participants from socioeconomically deprived and ethnically diverse backgrounds within Greater Manchester | 5 years | |
Secondary | Measures of prognostic model calibration and discrimination in a primary care population | Examples include calibration slope, intercept and Harrell's C statistic | 5 years | |
Secondary | Measures of prognostic model optimisation and accuracy with iterative variable inclusion or exclusion | Assess variable inclusion and exclusion using stepwise model selection and Wald statistic | 5 years | |
Secondary | Causal statistical analysis to determine effect of hypothetical interventions | Mediation analysis to determine causative effects of hypothetical interventions | 5 years | |
Secondary | Measures of cost effectiveness of the model in Greater Manchester | Examples include decision curve analysis | 5 years |
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