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
Protocol serial number	HTA 11/102/03
Sponsor	University Hospitals Bristol NHS Foundation Trust (UK)
Funder	Health Technology Assessment Programme

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Prof Barney Reeves
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

Email	barney.reeves@bristol.ac.uk

Study information

Primary study design	Observational
Study design	Longitudinal cohort study
Secondary study design	Cohort study
Study type	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(s)	All-cause mortality within 12 months
Key secondary outcome measure(s)	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
Completion date	31/01/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	50000
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

United Kingdom
England

Study participating centre

University of Bristol

Bristol
BS2 8HW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
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
Protocol article	protocol	02/05/2014	22/01/2019	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

22/01/2019: Publication references added
06/01/2017: No publications found, verifying study status with principal investigator.