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21/589 Coenzyme Q10 in chronic heart failure commissioning brief

Contents

Introduction

The aim of the HTA Programme is to ensure that high quality research information on the clinical effectiveness, cost-effectiveness and broader impact of healthcare treatments and tests are produced in the most efficient way for those who plan, provide or receive care from NHS and social care services. The commissioned workstream invites applications in response to calls for research on specific questions which have been identified and prioritised for their importance to the NHS, patients and social care.

Research question

What is the clinical and cost-effectiveness of coenzyme Q10 supplementation in chronic heart failure?

  1. Intervention: Coenzyme Q10 (ubiquinone) in addition to usual care. Formulation, dosage and product availability to be defined and justified by applicants.
  2. Patient group: Adults with chronic heart failure with a reduced ejection fraction (to be defined and justified by applicants). Applicants to consider sub-group analysis by heart failure severity (NYHA Classification. Applications are encouraged which include recruitment from geographic populations with high disease burden which have been historically underserved by research activity in this field and should include all people eligible for recruitment.
  3. Setting: Any appropriate setting (applicants to define and justify).
  4. Control: Placebo, in addition to usual care.
  5. Study design: A randomised controlled trial with an internal pilot phase to test key trial processes such as recruitment and adherence. Clear stop/go criteria should be provided to inform progression from pilot to full trial.
  6. Important outcomes: All cause hospitalisation; heart-failure related hospitalisation; major cardiovascular events; quality of life; all-cause and cardiovascular mortality; cost-effectiveness
  7. Other outcomes: Adverse events including potential interactions with other commonly used medications.  Existing Core Outcomes should be included amongst the list of outcomes unless a good rationale is provided to do otherwise. Applicants are encouraged to report recruitment and findings disaggregated by sex (and other demographic factors where relevant).
  8. Minimum duration of follow-up: To be defined and justified by applicants.
  9. Longer-term follow up: If appropriate, researchers should consider obtaining consent from participants to allow potential future follow up through efficient means (such as routine data) as part of a separately funded study.

Rationale

Heart failure is a complex clinical syndrome characterised by a malfunction of the pumping action of the heart which causes high filling pressures and/or reduced cardiac output. Its incidence and prevalence continue to rise due to an ageing population, improved survival rates following a heart attack and more effective treatments. In the UK, the most common type of heart failure is due to left ventricular systolic dysfunction, where there is impaired contraction of the left ventricle which is called heart failure with reduced ejection fraction (HFrEF).

Current treatment guidelines for chronic heart failure include the prescription of beta blockers, angiotensin converting enzyme inhibitors, angiotensin receptor blockers and aldosterone antagonists.
Coenzyme Q10 (CoQ10; also called ubiquinone) is an antioxidant, the main function of which is the production of adenosine triphosphate (ATP) through the electron transport chain. It has been shown in all tissues and organs in the body, with highest concentrations in the heart.

Available as an over-the-counter nutritional supplement there is a growing body of evidence, recently synthesised in a commissioned review by the NIHR HTA programme that CoQ10 improves functional outcomes in chronic heart failure and is relatively safe with few drug interactions and side effects.

A definitive adequately powered randomised controlled trial is now needed to determine if CoQ10 supplementation is indeed beneficial in heart failure.
If you are applying to this call you may request a confidential pre-publication version of the report by contacting htacommissioning@nihr.ac.uk

Additional commissioning brief background information

A background document is available that provides further information to support applicants for this call. It is intended to summarise what prompted the call and the existing evidence base, including relevant work from the HTA and wider NIHR research portfolio. It was researched and written on the basis of information from a search of relevant sources and databases, and in consultation with a number of experts in the field. If you would like a copy please email htaresearchers@nihr.ac.uk.

Making an application

If you wish to submit a Stage 1 application for this call, the online application form can be found on the funding opportunities page. To select this call, use the filters on the right of the screen or search using the call name and/or number.

Your application must be submitted on-line no later than 1pm on the 30 March 2022. Applications will be considered by the HTA Funding Committee at its meeting in May 2022.

Guidance notes and supporting information for HTA Programme applications are available.

Important: Shortlisted Stage 1 applicants will be given eight weeks to submit a Stage 2 application. The Stage 2 application will be considered at the Funding Committee in September 2022.

Applications received electronically after 1300 hours on the due date will not be considered.

For commissioned topics, the Programme strongly discourages the practice of the same co-applicant joining more than one competing team. There may be unusual circumstances where the same person could be included on more than on application eg a lead from a named charity or a unique national expert in a condition.

For such exceptions (i) each application needs to state the case as to why the same person is included (ii) the shared co-applicant should not divulge application details between teams and (iii) both teams should acknowledge in their application that they are aware that one of their co-applicants is part of a competing application and that study details have not been shared.

Should you have any queries please contact us by email: htacommissioning@nihr.ac.uk