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 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
Chief Investigator names: Dr Rachel Johnson, Dr Maria Pufulete
Trial Portfolio Lead: Jessica Frost