Optimise-HFpEF
Research type
Research Study
Full title
Optimising Management of Patients with Heart Failure with Preserved Ejection Fraction in Primary Care (Optimise-HFpEF)
IRAS ID
234872
Contact name
Christi Deaton
Contact email
Sponsor organisation
Cambridge University Hospitals NHS FT and University of Cambridge
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Heart failure (HF) is a condition in which the heart does not work well to pump blood around the body. About half of all people with HF have a type in which the heart is very stiff, which is called HF with preserved ejection fraction or HFpEF. This type is more common in older people with a history of high blood pressure, obesity and diabetes, but it is hard to diagnose and poorly understood. No specific drugs have been found to help it, except for diuretics or ‘water pills’. For now, recommendations for managing this type of HF focus on controlling blood pressure, blood sugar, and being active. Most patients are looked after in general practice sometimes in collaboration with specialists. In this study we want to identify and follow a group of patients (around 200) with HFpEF for a year to better understand their HF, their other conditions, needs for support, experience of treatment, and if they have problems requiring hospital care. We will ask people to come to a clinical research facility to collect information when they first enter the study, then 6 and 12 months later. Patients will have an echocardiogram (ultrasound of the heart), ECG, blood tests, a walking test and fill in questionnaires about how they feel and how they care for themselves. The walking test measures how far someone can walk at their own pace in six minutes. We will also check patients’ records at their GP’s office for medications and results of tests. This will help us understand what patients need. This study is part of a larger programme of work to develop the best (optimised) way of managing patients with HFpEF in primary care with specialist support. [COVID-19 amendment 22/05/2020] This amendment will also detail a COVID-19 sub study which we would like yo invite all participants to consider.\nAll participants when they consented to OPTIMISE HFpEF agreed they could be contacted about future, related research. As such, we would like to offer participants the opportunity to take part in this interview and survey based sub-study. The rationale for this study is that people with heart failure and other long term conditions are at increased risk of poorer outcome if exposed to COVID-19. They have also had to face changes in monitoring and service provision, confusing information on their ‘risk’ e.g. they are on NHS England’s list of ‘vulnerable’ groups but not the ‘shielded’ list and alarming press about the safety of angiotensin converting enzyme (ACE) inhibitors – a core heart failure medication (there has been speculation the COVID-19 virus infects cells through the Renin-Angiotensin-Aldosterone System (RAAS) pathway).\nThese unintended consequences likely pose the greatest risk to people with heart failure. We already know acute presentations across the board have been significantly reduced during the COVID-19 pandemic, with many hypothesizing this is due to concerns about catching the virus. However, much of this data comes from modelling and information collated during previous pandemics, particularly influenza. COVID-19 is different, we are witnessing high death tolls and curtailed activities through ‘lockdown’ beyond that of which we have seen with previous pandemics. Therefore, in addition to unintended consequences borne out of reconfigured health service, there will likely be other impacts of lockdown that we are not so aware of, such as isolation, loneliness,\nhardship, and even difficulties in obtaining essential items.\nIn addition to the above, there are likely to be long term changes in health care provision. Within our own\nresearch group we have already discussed changes that will likely happen ‘after’ COVID, for example continued greater use of remote methods of consulting. However, there is research that shows if these changes are not implemented in a considered and structured manner, they are at risk of poor uptake. Our patients are also less likely to use technology that allows visual contact thus limiting options for remote consultations. It is important that we capture views now, when we are at the peak of change in terms of lockdown and services provision, and that we consider how services may be permanently changed in future. The sample is large enough that we will also be able to capture evolution of view over time as lockdown is relaxed and services resume more ‘normal’ activities. Positive changes may well occur in health care as a result of the pandemic, including increased flexibility of services, triage of patients based on need, and innovative virtual consultations. However changes must be appropriate for older vulnerable patients such as those with HFpEF, and we won’t know unless we assess the situation now and over time. During interviews, if a participant becomes distressed in any way we would stop the recording and counsel the participant, we would also ask for their permission to link them in with/contact appropriate supporting services, generally this is their own GP or their local heart failure services. All the interviewers have significant experience of conducting interviews and if not healthcare professionals themselves, then are directly supervised by a healthcare professional who has the ability to escalate to health/social care services as necessary and follow up as needed to ensure support is in place. We also have a number of sign posts on our own website to resources that participants may find helpful. Survey respondents will also have contact details for the study team should the survey provoke any distressing thoughts or feelings. A similar COVID-19 related amendment has been submitted and approved in a qualitative sister study (IRAS#222689 REC # 17NE0199 Substantial Amendment 5- COVID-19) which is also had ’consent to contact’.
REC name
London - Surrey Research Ethics Committee
REC reference
17/LO/2136
Date of REC Opinion
30 Jan 2018
REC opinion
Further Information Favourable Opinion