Condition category
Circulatory System
Date applied
09/08/2013
Date assigned
14/08/2013
Last edited
14/08/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 the study is to find out whether BNP testing and monitoring improves outcomes for patients with heart failure.

Who can participate?
We aim to create a group of patients with heart failure (aged 18 years and above) to find out how they are cared for in the National Health Service (NHS), from diagnosis, through treatment, to outcome.

What does the study involve?
In order to do this, we will collate patient information from GP practices and hospitals, and link with hospital record data and death registry data. A small group of patients will have had BNP measurements recorded. We will compare groups with and without BNP measurements for differences in health outcomes. We will also undertake a health economic analysis 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?
The study will be carried out in the Clinical Trials and Evaluation Unit at the University of Bristol, UK.

When is study starting and how long is it expected to run for?
The study starts in August 2013. The study is not actively recruiting patients, as we will be using existing information collected as part of routine NHS care.

Who is funding the study?
The study is funded by the 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

1.0

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.

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

Condition

Heart failure

Intervention

Exposure: Any BNP measurement (single or multiple).
Comparator: No BNP measurement.

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

Clinical Trials and Evaluation Unit
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

National Institute for Health Research (NIHR) Heatlh Technology Assessment (HTA) Programme, UK (HTA 11/102/03)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes