Detecting EARLY Heart Failure in Greater Manchester
ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50+
SponsorManchester University NHS Foundation Trust
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
Primary care population with risk factors for heart failure
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No intervention
Other interventionNo 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.
Treatment groups
600 Participants
are divided into 1 treatment groupGroup A: Participants in primary care with risk factors for heart failure1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
5 yearsSecondary outcomes
1
Qualitative measures of primary care uptake and engagement
Number of participant identification sites, methods of participant identification, proportion of eligible participants contacted and recruited
Time frame
5 years2
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
Time frame
5 years3
Measures of prognostic model calibration and discrimination in a primary care population
Examples include calibration slope, intercept and Harrell's C statistic
Time frame
5 years4
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
Time frame
5 yearsSponsors and contacts
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Source ClinicalTrials.gov