Plain English Summary
Background and study aims
Permanent pacemakers are a common treatment for slow heart beats. In the UK 300,000 people have a pacemaker, and each year another 36,000 receive them. All of these patients are usually seen yearly to have their device checked. However, pacemaker technology is now very reliable, batteries last well over 5 years, and many patients require their pacemaker only occasionally as a backup.
Most visits involve checking the battery and the leads which, in the absence of symptoms, might be unnecessary. Pacemaker patients are at risk of developing other problems including heart failure which puts them at higher risk of hospitalisation and death. For those under follow-up, no mechanism exists to identify whether they might have heart failure, and for those receiving new implants, it is unclear which will go on to develop heart failure. Also, whether optimal heart failure treatment with a multidisciplinary team reduces the chances that they will be hospitalised is also unproven.
The aims of this study are to identify which patients are likely to develop complications and therefore which patients could be seen less frequently; to identify which patients should undergo screening for heart failure; and to find out whether such screening is cost-effective for reducing hospitalisation and death.
Who can participate?
Male and female patients aged 18 or over that have undergone (or had an attempted) implantation of a standard right ventricular permanent pacemaker.
What does the study involve?
During a routine pacemaker visit, patients will be invited to participate and will be randomly selected to either have an ultrasound of their heart (echocardiogram) or usual care. This will explore whether they have any structural heart problems.
What are the possible benefits and risks of participating?
Patients will be randomly allocated to having an ultrasound scan or usual care. The identification of previously unknown heart muscle weakness can lead to additional treatment and additional hospital visits which may or may not be of benefit (hence the study).
Where is the study run from?
The study will be running in Leeds, Bradford and Harrogate hospitals (UK)
When is the study starting and how long is it expected to run for?
June 2013 to March 2018
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Dr Klaus Witte
k.k.witte@leeds.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Klaus Witte
ORCID ID
Contact details
The Light Laboratories
University of Leeds
Clarendon Way
Leeds
LS2 9DA
United Kingdom
-
k.k.witte@leeds.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT01819662
Protocol/serial number
14378
Study information
Scientific title
Stratified care for patients with pacemakers
Acronym
OPT-PACE
Study hypothesis
Permanent pacemakers are a common treatment for slow heart beats. In the UK 300,000 people have a pacemaker, and each year another 36,000 receive them. All of these patients are usually seen yearly to have their device checked.
However, pacemaker technology is now very reliable, batteries last well over 5 years, and many patients require their pacemaker only occasionally as a backup.
Most visits involve checking the battery and the leads which, in the absence of symptoms might be unnecessary. Pacemaker patients are at risk of developing other problems including heart failure which puts them at higher risk of hospitalisation and death. For those under follow-up, no mechanism exists to identify whether they might have heart failure, and for those receiving new implants, it is unclear which will go on to develop heart failure. Also, whether optimal heart failure treatment with a multidisciplinary team reduces the chances that they will be hospitalised is also unproven.
My proposal therefore has three main aims:
1. Based on pacing indications and patient factors, to identify which patients are likely to develop complications and therefore which patients could be seen less frequently
2. To validate and refine a simple risk score to help identify which patients in pacing clinic should undergo screening for heart failure; and
3. To establish whether such screening and subsequent optimisation of those with heart failure is clinically and cost-effective for reducing hospitalisation and death.
Ethics approval
South Yorkshire, 25/10/2012, ref: 12/YH/0487
Study design
Interventional and observational randomised; Design type: Diagnosis, Prevention, Screening, Treatment, Cohort study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Heart Failure
Intervention
Interventions: The project has two workpackages and a randomisation and then a cohort phase.
During a routine pacemaker visit, patients will be invited to participate and will randomly be selected to have an ultrasound of their heart (echocardiogram) or not. In the presence of left ventricular dysfunction a policy of optimised therapy according to local policy as though this was 'normal' heart failure will be instituted.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Hospitalisation and mortality; Timepoints: 12 months
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/06/2013
Overall trial end date
01/03/2018
Reason abandoned
Eligibility
Participant inclusion criteria
1. Work package 1: We will prospectively enrol consecutive patients that have undergone (or had an attempted) implantation of a standard right ventricular (RV) permanent pacemaker (PPM) at Leeds General Infirmary into this observational study.
2. Work package 2: We will prospectively enrol consecutive attendees at pacemaker clinics in three hospitals in West Yorkshire.
3. Male & Female ; Lower Age Limit 18 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
UK Sample Size: 1800
Participant exclusion criteria
1. Work package 1: We will exclude patients with implantable cardioverter defibrillators (ICD) and cardiac resynchronisation pacemakers (CRT), but there will be no other exclusion criteria for adults (>18 years).
2. Work package 2:
2.1. We will exclude patients with implantable cardioverter defibrillators and cardiac resynchronisation pacemakers
2.2. Patients must be >18 years of age
2.3. Have had their pacemaker for >=12 months and
2.4. Not be under heart failure follow-up
Recruitment start date
01/06/2013
Recruitment end date
01/03/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Light Laboratories
Leeds
LS2 9DA
United Kingdom
Sponsor information
Organisation
University of Leeds (UK)
Sponsor details
Faculty Research Office
Room 10.110
Level 10 Worsley Building
Clarendon Way
Leeds
LS2 9NL
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
NIHR (UK) - Clinician Scientist Award Scheme; Grant Codes: NIHR-CS-012-032
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