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Effectiveness and cost-effectiveness of serum B-type natriuretic peptide (BNP or NT-BNP) testing and monitoring in patients with heart failure (HF) in primary and secondary care.

Funding body/stream

NIHR - Health Technology Assessment

Chief investigator

Professor Barney Reeves

Institution

University of Bristol & University Hospitals Bristol NHS Foundation Trust

Start dateand duration

From 1st January 2013 for 2 years

Amount

£ 225,372

Summary

Heart failure affects about 900,000 people in the UK. It happens when the heart becomes damaged, for example after a heart attack, and cannot pump blood around the body properly. B-type natriuretic peptide, and another chemical derived from it (collectively referred to as BNP), are hormones secreted by the heart in response to injury and their levels in the blood are raised in people with heart failure. High levels of BNP predict people who will experience a faster deterioration in their health from heart failure and who have a higher risk of serious disease events, such as death or deterioration in health requiring emergency admission to hospital.

There is some evidence that people with heart failure do better when BNP is measured regularly over time, so that doctors can adjust patients' drugs (used to treat heart failure, such as beta-blockers or ACE inhibitors) to try to lower BNP levels. Most of this evidence comes from randomised controlled trials, in which patients are allocated at random (by chance) to receive either BNP-guided treatment or standard treatment without having BNP measured. As part of our proposed project, we will bring together the results from all trials (in effect, averaging and improving the precision of the overall result) to determine whether those patients with heart failure who have BNP-guided treatment experience better outcomes than those who receive standard treatment (STUDY 1).

However, we expect it to be difficult to conclude that the overall finding from these trials should be applied to the general population with heart failure, whether managed by their GPs or hospital doctors, since the patients participating in clinical trials are not representative of the general population with heart failure - they are younger, with more men than women, having only a certain type of heart failure (reduced ventricular ejection fraction) and no other conditions. Also, most trials have been conducted outside the UK, making it difficult to determine whether measuring BNP is cost effective in the UK setting.

Therefore, we propose to supplement the IPD meta-analysis with analyses of a representative group of patients with heart failure in the UK (STUDY 2). We will create this patient group by linking data from the Clinical Practice Research Database (CPRD, which contains patient data from GP practices) and the UK National Heart Failure Audit (NHFA, which contains data on patients admitted to hospital with heart failure), as well as hospital record data and death registry data. These data will allow us to profile how heart failure patients are cared for in the NHS, from diagnosis, through treatment, to outcome. Both databases have a subset of patients who have had BNP values recorded. We propose to match these patients with a similar group of patients who have not had a BNP value recorded (taken from the same databases). We will compare groups with and without BNP measurements for differences in risk of death, hospital admission/readmission and length of hospital stay (for those e admitted to hospital), prescribed medications, number of outpatient appointments and patient management. We will also undertake a health economic analysis to determine whether measuring BNP is cost effective in the NHS (STUDY 3).

Impact

HF affects around 900,000 people in the UK, with an estimated prevalence of 6 to 10% in people over 65 years of age, increasing to 14% in people over 85 years of age. Prevalence is expected to increase as a result of the ageing population and improved survival of people with ischaemic heart disease. The prognosis of patients with HF is poor; up to 40% of newly diagnosed patients die within one year. HF is one of the most costly conditions to manage in the NHS; it accounts for 5% of all emergency medical admissions and consumes about 2% of the annual NHS budget. HF also markedly impairs quality of life. This research will determine whether BNP -guided therapy will improve outcomes for patients and whether it is cost -effective for the NHS.

The immediate output of the research will be:

1. Aggregate and IPD meta-analysis of the clinical effectiveness of BNP-guided therapy in patients with heart failure, including identification of clinically relevant subgroups of participants who benefit more than others from BNP-guided therapy and, potentially, information about how to optimise BNP guided therapy.

2. A comprehensive description of the current care pathway in the NHS, from diagnosis onwards, for a geographically representative sample of patients with heart failure in the UK.

3. A cost-effectiveness model, built on information from 1 and 2 and other routine data sources. The model will allow the cost-effectiveness of BNP-guided therapy in clinically relevant subgroups of participants to be estimated. Sensitivity analyses using the model will also describe how variation in key parameters of the model within plausible ranges (informed by uncertainty in the information from 1 and 2 and other routine data sources) impacts on the cost -effectiveness estimates for clinically relevant subgroups of participants.

We would expect the cost-effectiveness model to be adopted rapidly by commissioning groups and integrated into national guidance on BNP-guided therapy by the National Institute of Health and Clinical Excellence. In turn, we would expect these health policy impacts of the findings of the project to improve the health of patients in the UK with heart failure. Depending on the cost-effectiveness results, the project may increase NHS expenditure on heart failure. However, the outputs cost - effectiveness model will ensure that any such investment in heart failure is based on the best current evidence about cost-effectiveness and can be considered in the context of the cost -effectiveness of other uses of the investment.

Patient and public involvement

Patients were not actively involved in the preparation of the grant. The research question has been prioritised by the NHS (Commissioned research programme), and there is no 'active' data collection for the project. Nevertheless, we appreciate that patient and public involvement is critical for the project itself, especially with respect to interpretation of the findings of the project and their dissemination. Therefore, one of the team members is a patient with a past medical history of cardiovascular disease and heart failure.

Links to further information

http://www.nets.nihr.ac.uk/projects/hta/1110203

http://cteu.bris.ac.uk/our-trials/?trialType=Observational#1244