B-type natriuretic peptide (BNP) testing and monitoring in patients with heart failure (HF) in primary and secondary care in the UK
| ISRCTN | ISRCTN37248047 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37248047 |
| Secondary identifying numbers | HTA 11/102/03 |
- Submission date
- 09/08/2013
- Registration date
- 14/08/2013
- Last edited
- 22/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
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 |
Study information
| Study design | Longitudinal cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| 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 |
| Study objectives | 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(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/08/2013 |
| Completion date | 31/01/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | All patients for whom linked data are available (estimated to be ~50,000). |
| Key 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. |
| Key exclusion criteria | Patients who do not meet the inclusion criteria above |
| Date of first enrolment | 01/08/2013 |
| Date of final enrolment | 31/01/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
BS2 8HW
United Kingdom
Sponsor information
Hospital/treatment centre
c/o Dr Diana Benton
Research & Innovation
Level 3, Education Centre
Upper Maudlin Street
Bristol
BS2 8AE
England
United Kingdom
| diana.benton@uhbristol.nhs.uk | |
"ROR" |
https://ror.org/04nm1cv11 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NIHR Health Technology Assessment Programme, HTA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 02/05/2014 | 22/01/2019 | Yes | No |
| Results article | results | 01/08/2017 | 22/01/2019 | Yes | No |
| Results article | results | 31/07/2018 | 22/01/2019 | Yes | No |
| Results article | results of model-based cost-effectiveness analysis of B-type natriuretic peptide-guided care in patients with heart failure. | 28/12/2016 | 22/01/2019 | Yes | No |
| Results article | results of the healthcare costs of heart failure during the last five years of life. | 01/12/2016 | 22/01/2019 | Yes | No |
Editorial Notes
22/01/2019: Publication references added
06/01/2017: No publications found, verifying study status with principal investigator.
