A large trial will test whether heart failure patients can safely skip invasive angiography and instead use CT or MRI scans to diagnose the underlying cause. Coronary artery disease is the leading cause of heart failure, but current guidelines lack evidence on whether non-invasive imaging works as well as the standard invasive procedure for these patients. Patients themselves strongly prefer to avoid invasive angiography if it is safe. This trial randomly assigns patients to one of three diagnostic routes—invasive angiography, CT coronary angiography, or stress cardiovascular MRI—and tracks major cardiovascular events, quality of life, and cost-effectiveness over time. If non-invasive imaging proves non-inferior, the findings could directly change NICE and international guidelines, shifting routine heart failure diagnosis away from hospital-based invasive procedures toward outpatient scans. That would reduce patient discomfort, free up catheter lab capacity, and lower healthcare costs without compromising outcomes. The trial is designed to be inclusive of all heart failure types and uses electronic health records for follow-up, minimising burden on participants.
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RESEARCH QUESTION Does the first line investigation to determine heart failure aetiology impact subsequent patient outcomes? BACKGROUND Coronary artery disease (CAD) is the leading cause of heart failure and is commonly identified in those without prior history. It is possible to diagnose CAD using non-invasive cross-sectional imaging by computed tomography coronary angiography (CTCA) or stress cardiovascular magnetic resonance (stress CMR) but their effectiveness specifically in patients with heart failure has not been tested in multicentre settings. There are no UK data on the proportion of patients who get invasive angiography for investigation of heart failure but international rates range from 17 to 35%. It is clear from our PPI advisors that patients would prefer to avoid invasive coronary angiography (ICA) if safe to do so. AIMS AND OBJECTIVES To establish whether, in patients with heart failure, a strategy of non-invasive imaging is non-inferior to invasive coronary angiography in terms of major adverse cardiovascular events, patient reported outcome measures and cost-effectiveness. Our specific objectives include performing a trial that is inclusive of all patients; minimises inconvenience for patients; utilises electronic healthcare records for follow up; captures patient quality of life and acceptability; and encourages participation of the multidisciplinary heart failure team. METHODS We propose a multicentre, open-label randomised controlled trial of 3000 patients presenting with heart failure. Patients will be randomised in a 1:1:1 ratio to ICA, CTCA and stress CMR. We will recruit patients with both heart failure with preserved and reduced ejection fraction. Patients will be recruited from both inpatient and outpatient heart failure services. The inclusion criteria are: 1. Symptoms and/or signs of heart failure AND 2. Heart failure hospitalisation OR outpatients with NTproBNP >400ng/L Key exclusion criteria are history of prior ischaemic heart disease; clear alternative aetiology (such as hypertrophic cardiomyopathy or amyloidosis); severe primary valvular heart disease; and comorbid conditions with lifespan of less than one year. The primary endpoint is a composite of all-cause death, heart failure hospitalisation and myocardial infarction by a time to first event analysis. Follow up for the primary endpoint will be by review of electronic records at 12 months and then annually. The study is powered to demonstrate non-invasive imaging is non-inferior to ICA during a median follow up of at least 2 years. Questionnaires including EuroQol EQ-5D-5L, Kansas City Cardiomyopathy Questionnaire (KCCQ) and heart failure core outcomes will be conducted at baseline, 6, 12 months and then annually after randomisation, with the option to do them remotely (post or online). TIMELINES FOR DELIVERY The planned trial duration is 66 months including 6 months for setup, 42 months recruitment, minimum 12 months follow-up and 6 months for analysis and interpretation. 10 sites have already committed to opening in the pilot phase with recruitment of 5 patients per month. ANTICIPATED IMPACT AND DISSEMINATION This trial is designed to impact NICE and international guidelines for heart failure. National societies including BSH, BSCMR and BSCVI and our charity partner Cardiomyopathy UK will be instrumental in dissemination of findings to both public and policy makers.
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