CORAL

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 aged 18 years and above, 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: RRR-α-tocopherol (vitamin E), hydrogenated vegetable oil, refined soybean oil, red iron oxide (E172), black iron oxide (E172), glycerol, halal bovine gelatine
• 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

• Pregnant
• Breast feeding

Intervention and control

Patients will be randomly assigned to one of two groups:

Intervention group

The Intervention group will take Coenzyme Q10 (CoQ10) 100mg three times a day for 12 months.

Control group

The Control group will take a placebo 100mg three times a day for 12 months.

Contact us

• Chief Investigator names: Dr Rachel Johnson, Dr Maria Pufulete
• Trial Portfolio Lead: Jessica Frost
• Email: coral-study@bristol.ac.uk