Condition category
Circulatory System
Date applied
28/05/2008
Date assigned
26/06/2008
Last edited
14/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Allan Struthers

ORCID ID

Contact details

Department of Clinical Pharmacology
Division of Medicine and Therapeutics
Ninewells Hospital and Medical School
University of Dundee
Dundee
DD19SY
United Kingdom
+44 (0)1382 632180
a.d.struthers@dundee.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The potential to improve primary prevention by using brain natriuretic peptide (BNP) as an indicator of silent 'pancardiac' target organ damage

Acronym

The 5P Study

Study hypothesis

Despite controlling blood pressure (BP) and cholesterol, unexpected cardiac deaths still occur which means we need better ways of predicting those at high risk. A whole new possibility is to measure a substance in the bloodstream called brain natriuretic peptide (BNP), which should help identify silent heart disease which may otherwise progress to unexpected cardiac death. This work will see how good BNP is at identifying silent asymptomatic heart disease. The possibility is to use BNP for this purpose in the future so as to prevent unexpected cardiac deaths.

Study 1: What is the spectrum of cardiac target organ damage seen in those with an elevated BNP level?
Study 2: Does an elevated BNP in the absence of current ischaemia, left ventricular hypertrophy (LVH) or left atrial dilatation (LAD) identify those who will later develop LVH or LAD?

Ethics approval

Tayside Committee on Medical Research Ethics, 13/02/2008, ref: 08/S1402/15

Study design

Observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Not specified

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details provided in the Interventions field to request a patient information sheet.

Condition

Cardiovascular diseases

Intervention

This is an observational cohort study where participants will undergo standard diagnostic tests but no pharmacological, surgical or lifestyle interventions will be made.

Study 1: What is the spectrum of cardiac target organ damage seen in those with an elevated BNP level?

The Participants will all undergo a full clinical assessment including 24 hour BP monitoring. In addition, blood samples will be taken for the following:
1. Total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol and triglycerides (fasting)
2. BNP, N-terminal BNP and N-terminal Atrial Natriuretic Peptide (ANP). BNP will be measured by a near patient BNP test (Biosite®) and by a standard radioimmunoassay (RIA) on a sample stored at -70 C° using the Peninsula® kit. N-terminal ANP and N-terminal BNP will also be measured by commercially available RIA kits.
3. Kidney function will be measured in three ways
4. Microalbuminuria. We will also be able to assess the value of measuring both BNP and microalbuminuria to identify cardiac target organ damage (TOD).
5. Electrocardiogram (ECG) and 24 hour ECG tape to identify paroxysmal arrhythmias, especially atrial fibrillation (AF)
6. Echocardiography for target organ damage. All measurements will be made according to the American Society of Echocardiography (ASE) recommendation.
7. Silent coronary disease. A non-invasive technique is obviously necessary. We have opted for a dual approach, i.e. dobutamine stress echocardiography (DE) with nuclear stress perfusion imaging (SPI) as a back-up. The recent ACC/AHA 2002 guidelines for chronic stable angina were our guide in choosing techniques.
8. Cardiac MRI. This will be done in suitable patients identified at this stage, i.e. 76 individuals without any target organ damage. This is mainly so that we have baseline data to be used later for Study 2.

Study 2: Does an elevated BNP in the absence of current ischaemia, LVH or LAD identify those who will later develop LVH or LAD?

Effectively, a similar study to Study 1 will be repeated in some of the same individuals four years later. The main analysis will be whether LVMI and LAD progress more over 4 years in those with high tercile BNPs than in those with low tercile BNPs when both groups are matched for their baseline LVMI and LAD. It is best when studying intraindividual changes in LVMI (or LAD) to use the more sensitive technique of MRI.

The prime aim of Study 2 is to see if a high BNP could identify those whose LV mass and/or whose LA volume will increase more in the next 4 years as detected by MRI. We shall also for completeness see if BNP also identifies those who will develop new (silent) coronary disease and stress echo will be undertaken. In addition, for completeness a delayed gadolinium enhancement on MRI will be added to the standard LV quantitative MRI assessment as a validated way of detecting old myocardial infarctions (MIs). These will be done in both the initial MR and the follow up MR but only in those patients taking part in Study 2.

Please use the following contact details to request a patient information sheet:
Dr Adnan Nadir MBBS, MRCP
British Heart Foundation Research Fellow
Division of Medicine & Therapeutics
Ninewells Hospital & Medical School
University of Dundee, Dundee DD19SY, UK
Tel: +44 (0)1382 632 180
Fax: +44 (0)1382 644 972

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Study 1: The spectrum of cardiac target organ damage seen in those with an elevated BNP level
Study 2: Proportion of participants with elevated BNP in the absence of ischaemia, LVH or LAD who develop LVH or LAD at four years

Secondary outcome measures

No secondary outcome measures

Overall trial start date

18/02/2008

Overall trial end date

17/02/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Both males and females, age >50
2. Treated hypertensive and/or hypercholestrolemic
3. Primary prevention only i.e. no known ischaemic heart disease, cerebrovascular disease, heart failure or peripheral vascular disease

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant exclusion criteria

1. Renal impairment
2. Obvious cause for raised BNP level e.g., valvular disease or arrhythmias

Recruitment start date

18/02/2008

Recruitment end date

17/02/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Ninewells Hospital and Medical School
Dundee
DD19SY
United Kingdom

Sponsor information

Organisation

University of Dundee (UK)

Sponsor details

Research and Innovation Services
11 Perth Road
Dundee
DD1 4HN
United Kingdom
+44 (0)1382 384664
a.j.ward@dundee.ac.uk

Sponsor type

University/education

Website

http://www.dundee.ac.uk/research/index.html

Funders

Funder type

Charity

Funder name

British Heart Foundation (UK)

Alternative name(s)

BHF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

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

Publication citations

Additional files

Editorial Notes