Coenzyme Q10 for people with heart failure to improve their quality of life - the CORAL study

INTERVENTION: CORAL is a multi‐centre, individually randomized, pragmatic, patient‐centred, data‐enabled, placebo‐controlled superiority trial in primary care with internal pilot and economic evaluation. Participants will be recruited from primary care ( 75 GP surgeries in England) via NIHR Clinical Research Networks (CRN) including (but not limited to) the West of England, South West Peninsula, East Midlands and North East/North Cumbria. Adults with heart failure with reduced ejection fraction will be identified from electronic GP records. Following completion of the initial ineligibility checks of the components recorded in the GP medical records, potential participants identified will be sent an invitation pack. The invitation pack will contain an invitation letter (which will have a link to the online PIL and online expression of interest (EOI) form), a study summary, paper EOI and freepost envelope. Once an EOI has been received at the central research office at the Bristol Trials Centre, potential participants will either be sent a screening questionnaire by email or complete the screening questionnaire over the phone with a member of the research team. Following completion of the screening questionnaire, eligible participants will be sent a Participant Information Leaflet and given time to read it. A trained member of the research team will then speak with the patient, confirm understanding about the study and answer any questions, before receiving informed consent to take part in the study. Consent will also be sought for access to the participant’s medical records (HES, ONS and GP records) 12 months post‐randomisation and HES and ONS records again at 5 years post‐randomisation (subject to funding). It will be made clear that participants are free to stop their participation CONDITION: Heart failure with reduced ejection fraction ; Circulatory System PRIMARY OUTCOME: Participant‐reported heart failure specific measure of health‐related quality of life (HRQoL) assessed using the 23‐item self‐administered Kansas City Cardiomyopathy Questionnaire (KCCQ) at 12 months after randomisation. These data will also be collected at four other timepoints (baseline, 3, 6, and 9 months after randomisation) via self‐reported questionnaires. INCLUSION CRITERIA: 1. Adults =18 years 2. Evidence in the GP record of left ventricular systolic dysfunction 3. Self‐reported New York Heart Association (NYHA) class of =II (physical activity triggers symptoms of heart failure to some degree) SECONDARY OUTCOME: Defined from routine or patient reported data: ; 1. All‐cause death, all‐cause hospitalisation and HF‐specific HRQoL analysed using the win ratio, collected via routine data and participant‐reported HRQoL (KCCQ) at 12 months and 5 years post‐randomisation (subject to funding) ; 2. All‐cause death, collected via routine data at 12 months and 5 years post‐randomisation (subject to funding) ; 3. Cardiovascular death, collected via routine data at 12 months and 5 years post‐randomisation (subject to funding) ; 4. All‐cause hospitalisations, collected via routine data at 12 months and 5 years post‐randomisation (subject to funding) ; 5. Cardiovascular hospitalisation, collected via routine data at 12 months and 5 years post‐randomisation (subject to funding); 6. Heart failure specific hospitalisation, collected via routine data at 12 months and 5 years post‐randomisation (subject to funding) ; 7. Major adverse cardiovascular events (MACE) including death, cardiovascular hospitalisation, mechanical assist implantations or urgent cardiac transplantations, collected via routine data at 12 months and 5 years post‐randomisation (subject to funding) ; 8. Resource and health service use, collected via routine data at 12 months and 5 years post‐randomisation (subject to funding) ; 9. New York Heart Association (NYHA) functional classification collected via self‐reported questionnaire at baseline, 3, 6, 9 and 12 months post‐randomisation ; 10. Quality of life assessed using the EQ‐5D‐5L questionnaire collected via self‐reported questionnaire at baseline, 3, 6, 9 and 12 months post‐randomisation ; 11. Formal and informal care collected via self‐reported questionnaire at baseline, 3, 6, 9 and 12 months post‐randomisation ; 12. Time off paid employment collected via self‐reported questionnaire at baseline, 3, 6, 9 and 12 months post‐randomisation ; 13. Adverse events related to the study interventions collected via self‐reported questionnaire at 3, 6, 9 and 12 months post‐randomisation; 14. Self‐reported adherence to study interventions collected via self‐reported questionnaire at 3, 6, 9 and 12 months post‐randomisation