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: In set up

Sponsor: University of Bristol

Aim: In patients with heart failure with reduced ejection fraction (HFrEF), is the addition of Coenzyme Q10 (CoQ10) to usual care clinically and cost-effective?

Design: Pragmatic, patient-centred, data enabled, placebo-controlled randomised controlled trial (RCT), with internal pilot and economic evaluation.

Overall participant target: 950 patients with heart failure.

Project Timeline: Trial duration 42 months: 8-months set up, 14-months recruitment (6-months internal pilot, 8-months main trial), 12-months follow up, 8-month analysis and reporting.

Inclusion Criteria: Adults ≥18 years with a diagnosis of HF, evidence in GP record of left ventricular systolic dysfunction (LVSD), New York Heart Association (NYHA) class of II or above.

Exclusion Criteria: Participants may not enter the trial if ANY of the following apply:

  • Diastolic dysfunction with EF≥50% or preserved left ventricular function
  • Current warfarin use (CoQ10 may reduce the anticoagulant effect of warfarin)
  • Known allergy to CoQ10 or its constituents*
  • Known allergy to soy
  • Known allergy to peanuts
  • Currently enrolled in another interventional clinical trial
  • Unable to provide informed consent
  • Unwilling to take part due to diet choices (placebo and CoQ10 capsules contain halal bovine gelatine)
  • Women only:
    o Pregnant
    o Breast feeding
  • * RRR-α-tocopherol (vitamin E), hydrogenated vegetable oil, refined soybean oil, red iron oxide (E172), black iron oxide (E172), glycerol, halal bovine gelatine.

Intervention/Control: Patients will be randomly assigned to one of two groups:

  • the Intervention group will take Coenzyme Q10 (CoQ10) 100mg three times a day for 12 months
  • the Control group will take a placebo 100mg three times a day for 12 months

Contact Information

Chief Investigator names: Dr Rachel Johnson, Dr Maria Pufulete

Trial Portfolio Lead: Jessica Frost