£2.4 million awarded by NIHR HTA to fund new REACH-HFpEF trial

Posted by stjm202

The Universities of Dundee, Glasgow, Exeter, Birmingham, Cambridge and York have received £2.4 million to lead a clinical trial of a home-based cardiac rehabilitation programme for people with heart failure with preserved ejection fraction and their caregivers. The National Institute for Health Research (NIHR) Health Technology Assessment Programme funding will allow them to undertake a multicentre trial to assess the patient benefits and cost-effectiveness of the REACH-HF intervention, which aims to improve quality of life for people with heart failure with preserved ejection fraction (HFpEF) and their caregivers.

Project Summary

Aim?

To find out whether a home-based rehabilitation programme in people with heart failure with preserved ejection fraction and their caregivers is effective and cost-effective.

Importance of the research?

Half of all people with heart failure have heart failure with preserved ejection fraction (or ‘HFpEF’). HFpEF is a complex condition of the heart that affects older individuals who typically have a number of concomitant diseases, including diabetes and high blood pressure. HFpEF has severe impacts on both patients and health care systems, including: a markedly reduced ability to undertake activities of daily living, greatly reduced quality of life, and highly increased risk of unplanned hospital admissions, resulting in high NHS costs. Drug and device therapies shown to work in people with the other type of heart failure (heart failure with reduced ejection fraction) don’t work in HFpEF. As a result, the 400,000 patients in the UK who have HFpEF are effectively living with untreated heart failure, with potentially devastating consequences for themselves and their families.

With prior NIHR funding, we designed a home-based rehabilitation intervention to promote physical and mental well-being and support self-management for people with heart failure and their caregivers: ‘REACH-HF’. In a pilot study in 50 patients and their cares we showed that people with HFpEF are willing to participate in this type of research, have their outcomes assessed, and that they engaged well with the REACH-HF intervention. We also saw promising effects of REACH-HF captured by this quote from one of the pilot study participants: “…you should not underestimate the importance of this as a positive intervention for HFpEF patients and their caregivers”. A recent systematic review (of 8 small pilot trials of short duration) supports our pilot findings of a potential clinically important effect of exercise-based rehabilitation for HFpEF. However, due to the lack of strong evidence of its effectiveness or cost-effectiveness, our recent national survey shows cardiac rehabilitation is not currently available for this group of patients. We will now undertake a ‘definitive trial’ to help inform the NHS as to whether REACH-HF should be rolled out for people with HFpEF.

Plan?

520 HFpEF patients (and their carers) will receive either REACH-HF plus usual care or usual care only. The main patient outcome will be a widely used quality of life measure: Minnesota Living with Heart Failure Questionnaire. Other patient outcomes include: mental wellbeing, level of physical activity, hospital admissions; plus carer’s quality of life and burden. We will also assess how well the intervention is delivered, what factors may influence responsiveness to the intervention (e.g. patient age, severity of disease, education) and collect information on costs. Interviews with patients and carers will help us to inform NHS roll out, if the trial is positive.