Condition category
Circulatory System
Date applied
17/05/2013
Date assigned
17/05/2013
Last edited
19/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

http://www.leeds.ac.uk/

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

Publication citations

Additional files

Editorial Notes

19/05/2016: the overall trial end date was changed from 01/05/2015 to 01/03/2018.