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 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.
The home-based rehabilitation intervention has been developed by the REACH-HF multidisciplinary team, which was recently recognised as BMJ 2020 Stroke and Cardiovascular team of year for its ability to deliver cardiac rehab in these challenging times.
Approximately one million people in the UK have heart failure – a condition resulting in inefficient cardiovascular functioning, often presenting with debilitating symptoms of fatigue, shortness of breath and a potentially dangerous accumulation of fluid in bodily tissues.
Heart failure has a significant negative impact upon patients’ health-related quality of life and often results in unplanned hospital admissions. Currently, heart failure costs the National Health Service more than £2 billion each year, with around 70% of this cost being as the result of hospitalisations.
There are two main forms of the disease – HFpEF and heart failure with reduced ejection fraction (HFrEF). In contrast to HFrEF, the prevalence of HFpEF has increased in the past decade, and is projected to continue to increase relative to the ageing population.
In people with reduced ejection fraction, the heart pumps poorly, whereas in HFpEF, the heart continues to pump effectively but fails to relax sufficiently giving rise to a ‘stiff heart’. People with both forms of the disease present with similar symptoms, including as fluid retention and shortness of breath, and are both at increased risk of hospital admission.
Whilst there are a selection of effective drug therapies to treat people with reduced ejection fraction, there is a paucity of safe and effective treatments available for HFpEF. REACH-HF has been shown to hold promise for HFpEF, with a single-centre pilot study in Dundee showing that the intervention is acceptable to people with HpEF and their caregivers, and can lead to a meaningful improvement in quality of life.
“There is an urgent unmet need for new treatments for heart failure with preserved ejection fraction,” said REACH-HFpEF study co-chief investigator Professor Chim Lang, from Dundee’s School of Medicine. “Heart failure is a major public health problem that cost the NHS billions each year as well as significantly impacting on the quality of life of patients and their carers. It proves fatal in up to 30% of cases.
“Exercise has shown a lot of promise as a non-pharmacological therapy, but the nature of this disease means that it is often difficult to get out of the house and this has only been exacerbated by the Covid-19 pandemic.
“Therefore, we believe a tailored programme of home-based cardiac rehabilitation such as REACH-HF has enormous potential to improve outcomes while reducing the burden on health systems. REACH-HF is 12-week multicomponent intervention that includes exercise training, psychological support, and education on self-management that is facilitated by health professional, such as cardiac nurse or physiotherapist.
“One of the most appealing elements of an intervention such as this is that it empowers patients to take ownership of their own treatment and health and that is a real motivation for many to get better.”
On average there are some 200,000 new cases of heart failure in the UK each year, with up to 50% of these being HFpEF patients. As well as measuring the improvement of patients in clinical terms, REACH-HF will also look at the savings the intervention delivers and how this would be multiplied across the NHS.
The study aims to recruit 520 patients with HFpEF and their caregivers across 15 sites across England, Scotland, and Wales. The REACH-HFpEF study will be the largest international trial of rehabilitation in HFpEF to date.
REACH-HF trial co-chief investigator, Professor Rod Taylor from the University of Glasgow’s Institute of Health & Wellbeing, said, “We are delighted to have received this funding from NIHR to allow us to work with people with HFpEF and those that support their care and undertake this important trial.
“This project represents a collaboration between researchers at institutions including the Universities of Birmingham, Exeter, Cambridge, and York and NHS clinicians across the country. We would like to acknowledge the support of the UK’s heart failure patient-led charity ‘Pumping Marvellous’ in securing this funding.
“With little or no existing evidence-based treatments, people with HFpEF have high unmet treatment need. This trial therefore represents an important opportunity to study making exercise-based rehabilitation routinely available as an effective and value for money treatment for this group, especially in a home-based format given the challenging ongoing COVID-19 pandemic.
“Our results will hopefully inform future national and international guidelines for the management of HFpEF.”
The study is being supported by the Robertson Centre for Biostatistics at the University of Glasgow and the Glasgow Clinical Trials Unit.