EVOLUTION HF UK
Research type
Research Study
Full title
Early treatment of heart failure: a non-interventional observational study program of patients with heart failure and initiated on dapagliflozin (EVOLUTION-HF UK)
IRAS ID
296166
Contact name
Steven Coombs
Contact email
Sponsor organisation
AstraZeneca
Duration of Study in the UK
1 years, 8 months, 31 days
Research summary
Summary of Research
The overall aim of this study is to describe the characteristics of patients started on dapagliflozin for the treatment of heart failure (HF) and to provide information on treatment patterns, as well as patient-reported outcomes (PROs) including quality of life. \n\nThis research is important because HF is a global, public health issue that affects more than 63 million people worldwide; this burden is expected to increase substantially as the population ages. Despite advancements in treatment, a HF diagnosis still leads to significant morbidity and mortality; there is also an immense impact on patients’ health-related quality of life (HRQoL).\n\nClinical information will be collected from the health records of patients enrolled. Additional data such as PROs will be collected directly from patients. Data collection will involve assessments at enrolment into the study, and separate follow-up assessments at 3, 6, 9 and 12 months following enrolment.\n\nThe research will take place at about 10 hospitals across the UK and is sponsored by AstraZeneca UK.
Summary of Results
Heart failure (HF) is a common heart condition, that can be caused by health problems such as heart disease, high blood pressure, heart rhythm problems, type 2 diabetes or chronic kidney disease. Heart failure with reduced ejection fraction (HFrEF) is a type of HF where the left side of the heart does not pump blood well to the rest of the body.
HFrEF has many symptoms, like difficulty breathing, coughing during sleep, less ability to exercise, extreme tiredness and ankle swelling. These symptoms have a big impact on how patients feel, and can limit their day-to-day activities.
Dapagliflozin is a medication which was already used for type 2 diabetes and chronic kidney disease. Clinical trials showed it also reduced symptoms for HFrEF patients, with less time spent in hospital and fewer deaths. Because of this, in 2020 dapagliflozin was approved in the UK to treat patients with HFrEF.
To help understand how dapagliflozin is being used in the UK, and if this medication helps people in the real world (not just in clinical trials), we did research which aimed to look at the medical information of real patients with HFrEF taking dapagliflozin. We also asked how their HFrEF affects their everyday life.We asked 237 adult patients to complete questions about their everyday life every three months over 1 year. We also asked their doctors to complete questions about their medical care. Patient identities were not known to the researchers. Ten hospitals across the UK helped us with this research. Patients were asked if they wanted to take part shortly after they first started taking dapagliflozin for their HFrEF.
We looked at patients’ medical history, including use of medications and heart function. We asked patients if they took dapagliflozin as advised by their doctors, and about the effects of HFrEF on their everyday life. This included how bad their symptoms were, and the effect of HFrEF on work, social life and daily activities.
Currently, patients who start dapagliflozin are asked to take the treatment alongside three other drugs. Just over half of patients in our study were at first prescribed dapagliflozin with the recommended other drugs. However, doctors often did change patients’ other treatments after they started taking dapagliflozin. This might mean that doctors were trying different ways to find the best overall treatment to improve their patients’ symptoms and outcomes.
Patients reported they took dapagliflozin as they were asked to, and very few stopped taking dapagliflozin during the research. For the 21 patients who did stop taking dapagliflozin, this was usually because of a side effect of the medication, or any other unexpected reaction not caused by dapagliflozin.
Most patients reported that their quality of life was fair-to-good, and that their symptom control was good-to-excellent during the research. This shows that patients thought their disease was well controlled while taking dapagliflozin, and their symptoms and everyday life did not get worse. However, patients did say their disease had a big impact on their work and ability to carry out day-to-day activities.
Overall, the research showed that patients had no major problems taking dapagliflozin, and very few stopped taking the treatment. Patients had a fair-to-good quality of life, but did still face challenges with work and daily activities. Further research is needed to look at the effects of dapagliflozin over a longer period of time, and how it is used with other medications.REC name
North of Scotland Research Ethics Committee 2
REC reference
21/NS/0102
Date of REC Opinion
4 Aug 2021
REC opinion
Favourable Opinion