Plain English Summary
Background and study aims
B-type natriuretic peptide (BNP) is a substance in the blood that is raised in patients with heart failure. There is evidence that measuring BNP regularly over time and adjusting medications to lower BNP levels improves health outcomes in these patients. Currently, it is unknown whether any heart failure patients in the UK receive serial BNP monitoring and, if yes, whether this has changed patient management and improved clinical outcomes. The main aim of this study is to find out whether BNP testing and monitoring improves outcomes for patients with heart failure.
Who can participate?
Patients with heart failure aged 18 and over
What does the study involve?
Patient information is collated from GP practices and hospitals, and linked with hospital record data and death registry data. A small group of patients have BNP measurements recorded. Groups with and without BNP measurements are compared for differences in health outcomes. A health economic analysis is also undertaken to determine whether measuring BNP is cost effective in the NHS.
What are the possible benefits and risks of participating?
There will be no risk to patients because all information will be provided in a format that will not include names, addresses, date of birth, or any other identifiable information.
Where is the study run from?
University of Bristol (UK)
When is the study starting and how long is it expected to run for?
August 2013 to January 2015
Who is funding the study?
National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme (UK)
Who is the main contact?
Dr Maria Pufulete
maria.pufulete@bristol.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Barney Reeves
ORCID ID
Contact details
Clinical Trials and Evaluation Unit
School of Clinical Sciences
University of Bristol
Level 7
Bristol Royal Infirmary
Queen's Building
Bristol
BS2 8HW
United Kingdom
-
barney.reeves@bristol.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 11/102/03
Study information
Scientific title
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
Acronym
Study hypothesis
Compared with symptom-guided therapy (standard care), BNP-guided testing and monitoring reduces mortality and hospital admission in patients with chronic heart failure in the UK and is cost effective to the NHS.
More details can be found at: https://www.journalslibrary.nihr.ac.uk/programmes/hta/1110203/#/
Ethics approval
The cohort will be established by the UK Clinical Practice Research Datalink (CPRD), which holds standing ethical approval for observational studies using anonymised CPRD GOLD data. Our study therefore does not require separate ethical approval from an NHS Research Ethics Committee.
Study design
Longitudinal cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Heart failure
Intervention
Exposure: Any BNP measurement (single or multiple).
Comparator: No BNP measurement.
Patient information is collated from GP practices and hospitals, and linked with hospital record data and death registry data. A small group of patients have BNP measurements recorded. Groups with and without BNP measurements are compared for differences in health outcomes. A health economic analysis is also undertaken to determine whether measuring BNP is cost effective in the NHS.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
All-cause mortality within 12 months
Secondary outcome measures
1. Time from diagnosis of HF (time origin for all time-to-event analyses) to emergency in hospital admission/unscheduled readmission
2. Length of hospital stay
3. Prescribed medications on discharge
4. Time on medication
5. Time to change in medication
6. Annual rate of outpatient clinic and general practice attendance and associated investigations
Overall trial start date
01/08/2013
Overall trial end date
31/01/2015
Reason abandoned
Eligibility
Participant inclusion criteria
All patients with primary diagnosis of heart failure in CPRD or NHFA, diagnosed between April 2005 and March 2013 (CPRD) and April 2009 and March 2013 (NHFA). HF diagnoses in CPRD will be identified using the Read codes. Code sets will be selected with the help of CPRD researchers and agreed by clinical members of the research team.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
All patients for whom linked data are available (estimated to be ~50,000).
Participant exclusion criteria
Patients who do not meet the inclusion criteria above
Recruitment start date
01/08/2013
Recruitment end date
31/01/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Bristol
Bristol
BS2 8HW
United Kingdom
Sponsor information
Organisation
University Hospitals Bristol NHS Foundation Trust (UK)
Sponsor details
c/o Dr Diana Benton
Research & Innovation
Level 3
Education Centre
Upper Maudlin Street
Bristol
BS2 8AE
United Kingdom
-
diana.benton@uhbristol.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Health Technology Assessment Programme
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary