Background

Heart failure (HF) is a common long-term condition where the heart struggles to pump effectively, resulting in symptoms of breathlessness, fatigue and oedema. People with heart failure with preserved ejection fraction (HFpEF) have symptoms of heart failure even though their heart pumps sufficiently (with ≥50% ejection fraction). HFpEF accounts for about 50% of all HF cases and its prevalence increases with age, from 1% of people aged <60 years to around 6% of people aged >80 years. About half of people with HFpEF have coexisting frailty, a condition characterised by loss of biological reserves, failure of physiological mechanisms, and increased vulnerability to a range of adverse outcomes. HFpEF combined with frailty identifies people who are at especially high risk of adverse outcomes.

Existing NHS services are not well developed for older people with co-existing HFpEF and frailty. Geriatricians and other healthcare professionals, who specialise in the healthcare of older people with frailty, are well-positioned to lead and coordinate new multidisciplinary pathways of care for people with coexisting HFpEF and frailty through Comprehensive Geriatric Assessment (CGA). CGA is a multidimensional process involving the assessment of an individual’s medical, functional, social, environmental and psychological needs to develop an agreed management plan through shared decision making and a plan for routine follow-up. Rehabilitation is a key component of the CGA approach, helping people to do what is important to them.

Aims & Objectives

The CHART trial aims to establish whether CGA including a 12-week progressive rehabilitation programme (plus usual care) is a clinically and cost-effective intervention to sustain independence in Instrumental Activities of Daily Living (IADL) for older people with HFpEF and frailty when compared with usual care alone.

Objectives:
The primary objective is to establish whether CGA including a 12-week progressive rehabilitation programme (plus usual care) sustains IADL, measured using the NEADL, 12 months after randomisation.

Other objectives include:

  1. To establish whether participant recruitment and intervention fidelity rates, following a 9-month internal pilot meet pre-defined progression criteria to warrant continuation of the trial.
  2. To establish whether the intervention reduces hospitalisation (all-cause; HF-specific; falls), major adverse cardiac and cerebrovascular events (MACCE) and mortality at 6, 12 and 24 months, using Hospital Episode Statistics (HES) and Civil Registrations data.
  3. To establish whether the intervention sustains basic ADL (measured using the Barthel Index), health-related quality of life (measured using the EuroQol 5-dimension health questionnaire (5-level), EQ5D-5L), and mental health (measured using the 8-item Patient Health Questionnaire, PHQ-8), at 6 and 12 months.
  4. To establish whether the intervention improves days alive and out of hospital at 6, 12 and 24 months.
  5. To establish whether the intervention reduces home care requirement, new care home placement, and overall health and social care resource use at 6 and 12 months.
  6. To establish whether the intervention is cost-effective using within-trial analysis and a Decision Analytic Model (DAM) with a life-time time horizon, considering outcomes from the traditional health perspective (health-QALYs) using EQ5D-5L and ICECAP-O.
  7. To understand how the intervention is experienced and understood by providers and recipients.
  8. To evaluate the delivery, receipt and enactment of the intervention using mixed qualitative and quantitative methods and finalise the intervention theory to inform ‘real-world’ NHS delivery.

Methods

A pragmatic, multicentre, individually randomised, parallel group randomised controlled trial (RCT) with internal pilot and embedded process and cost-effectiveness evaluations.

Population: Older people (aged ≥65) living with HFpEF and frailty, recruited via secondary care HF services, including retrospective screening of electronic patient records and heart failure clinic letters, and via the National Institute for Health and Care Research – British Heart Foundation Cardiovascular Partnership (NIHR BHFCP) national HFpEF registry.

Intervention: CGA using a structured tool, with tailored management plan and follow-up, including a 12-week progressive rehabilitation programme, plus usual care.

Partners & Collaborators

Investigators

Prof Andrew Clegg (Joint Lead), Prof Vicki Goodwin (Joint lead), Prof Chris Bojke, Associate Prof Michelle Collinson, Ms Florence Day, Prof Amanda Farrin, Associate Prof Julia Frost, Prof Chris Gale, Dr Jane Masoli, Mrs Naomi Morley, Mrs Lynn Tatnell, Dr Oliver Todd, Dr Lauren Walker, Dr Emma Vardy

List of Collaborators

  • Academic Unit for Ageing and Stroke Research, University of Leeds
  • Bradford Institute of Health Research, Bradford Royal Infirmary, Bradford Teaching Hospitals NHS Foundation Trust
  • Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds
  • Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds
  • University of Exeter Medical School
  • University of Liverpool
  • Northern Care Alliance NHS Foundation Trust

Timescales

01/03/2024 – 14/02/2029

Funding agency

National Institute for Health and Care Research (NIHR)

Further information

This summary presents independent research funded by the National Institute for Health and Care Research Health Technology Assessment Programme (NIHR HTA) (Award ID: NIHR155936). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.

Ethical Approval: Yorkshire & The Humber – Leeds East Research Ethics Committee (REC Reference 24/YH/0185)

Trial Registry: ISRCTN Registry ISRCTN 22229432 https://www.isrctn.com/pdf/22229432

For further information contact Project Co-Lead: Professor Andrew Clegg or Trial Manager: Dr Seline Ozer