Optimising Pacemaker Therapy (OPT-PACE)
| ISRCTN | ISRCTN47059787 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47059787 |
| ClinicalTrials.gov number | NCT01819662 |
| Secondary identifying numbers | 14378 |
- Submission date
- 17/05/2013
- Registration date
- 17/05/2013
- Last edited
- 09/08/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
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
Contact information
Scientific
The Light Laboratories
University of Leeds
Clarendon Way
Leeds
LS2 9DA
United Kingdom
| k.k.witte@leeds.ac.uk |
Study information
| Study design | Interventional and observational randomised; Design type: Diagnosis, Prevention, Screening, Treatment, Cohort study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Stratified care for patients with pacemakers |
| Study acronym | OPT-PACE |
| Study objectives | 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(s) | South Yorkshire, 25/10/2012, ref: 12/YH/0487 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Hospitalisation and mortality; Timepoints: 12 months |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/06/2013 |
| Completion date | 01/03/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | UK Sample Size: 1800 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/06/2013 |
| Date of final enrolment | 01/03/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
LS2 9DA
United Kingdom
Sponsor information
University/education
Faculty Research Office
Room 10.110, Level 10 Worsley Building
Clarendon Way
Leeds
LS2 9NL
England
United Kingdom
| Website | http://www.leeds.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/024mrxd33 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Preliminary results presented at EHRA 2019 (https://esc365.escardio.org/Congress/EHRA-2019/Late-breaking-trials-4/194671-the-opt-pace-ttria-optimising-pacemaker-and-medical-therapy-in-pacemaker-patients-for-heart-failure#slide). |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 17/07/2019 | 09/08/2019 | Yes | No |
Editorial Notes
09/08/2019: Publication reference added.
29/04/2019: Publication and dissemination plan added.
16/04/2019: No publications found, verifying study status with principal investigator.
19/05/2016: the overall trial end date was changed from 01/05/2015 to 01/03/2018.
