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

The effectiveness and cost effectiveness of COenzyme Q10 in heaRt fAiLure with reduced ejection fraction (CORAL): a pragmatic, patient-centred, data-enabled trial in primary care

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN26946710

Enrollment

950

Registered

2024-05-15

Start date

2025-02-21

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure with reduced ejection fraction Circulatory System

Interventions

Current interventions as of 12/02/2026: CORAL is a multi-centre, individually randomized, pragmatic, patient-centred, data-enabled, placebo-controlled superiority trial in primary care with internal p

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

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)

Exclusion criteria

Exclusion criteria: Current exclusion criteria as of 12/02/2026: 1. Diastolic dysfunction with no evidence of left systolic dysfunction 2. Supplementary CoQ10 intake within the last 6 weeks 3. Current warfarin use (CoQ10 may reduce the anticoagulant effect of warfarin) 4. Known allergy to soy 5. Known allergy to peanuts 6. Currently enrolled in another interventional clinical trial 7. Unable to provide informed consent 8. Unwilling to take part due to diet choices (placebo and CoQ10 capsules contain halal bovine gelatine) Women only: 9. Pregnant 10. Breastfeeding Previous exclusion criteria: 1. Diastolic dysfunction with EF =50% or preserved left ventricular function 2. Supplementary CoQ10 intake within the last 6 weeks 3. Current warfarin use (CoQ10 may reduce the anticoagulant effect of warfarin) 4. Known allergy to soy 5. Known allergy to peanuts 6. Currently enrolled in another interventional clinical trial 7. Unable to provide informed consent 8. Unwilling to take part due to diet choices (placebo and CoQ10 capsules contain halal bovine gelatine) Women only: 9. Pregnant 10. Breastfeeding

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

England, United Kingdom

Contacts

Public ContactBarbara Warnes

coral-study@bristol.ac.uk+44 (0)117 455 6725

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026