Pacemaker ComplicationPhase 3OPT-paceNCT01819662
Optimised Pacing Program
A Phase 3 study testing Enhanced standard management, Optimised heart failure management and Standard management in people with Pacemaker Complication and Congestive Heart Failure, run by University of Leeds at 3 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pacemaker Complication, Congestive Heart Failure
- What is being tested?
- Enhanced standard management, Optimised heart failure management and Standard management
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,793 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 1 Aug 2013to 28 Feb 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pacemaker implantation
Who cannot join
- Dementia, unwilling to fill in quality of life questionnaires, unwilling to sign consent form
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Bradford Hospitals NHS Foundation Trust
Bradford, Yorkshire
Harrogate Hospital Foundation Trust
Harrogate, Yorkshire
Leeds General Infirmary
Leeds
About this study
Official title: Stratified Management of Patients With Pacemakers
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 back-up. Each visit costs around £200 such that pacemaker follow-up cost the NHS around £50million per year. 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.
Our study 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.
Read the detailed description
Permanent pacemaker implantation is a safe, life-prolonging and cost-effective treatment for bradycardia. An estimated 300,000 people in the UK have a pacemaker and there are 36,000 new implants per year. Complications from pacemaker implantation occur in 5-15% of patients, mostly in the first six weeks. After six months new problems are very rare. Clinic follow-up of patients with a PPM usually occurs at six weeks, three months and then annually to monitor battery performance. Reprogramming is rarely required, and batteries reliably last at least five years. The tariff for pacemaker follow-up is £200 costing the National Health Service (NHS) £50 million per year.
The commonest and most under-recognised long-term complication of pacemaker implantation is pacemaker-related chronic heart failure (CHF) due to left ventricular systolic dysfunction, seen in up to 50% of patients. Published data examining the incidence and associations of pacemaker-related cardiac dysfunction consist of retrospective cross-sectional analyses or data taken from other studies rather than a-priori planned analyses. Our unique pilot data in almost 500 patients show that cardiac dysfunction is present in 40% of all pacemaker patients and confirm previous suggestions that it is more common in patients with an underlying predisposition, for example cardiovascular co-morbidities (including diabetes mellitus), with high rates of pacing and atrial fibrillation. Our data also demonstrate that patients with cardiac dysfunction and a pacemaker are not usually taking optimal medical therapy for their heart failure and suffer a 13% annual combined heart failure hospitalisation or death rate (compared to 6% in pacemaker patients without cardiac dysfunction, and ~8% in patients with CHF attending the Leeds Integrated Heart Failure Service). However, since patients with pacemakers were often excluded from the large studies of medical (and device) therapy of CHF, it is unclear whether optimisation of medical (and pacemaker) therapy in patients with pacemaker-related cardiac dysfunction can reduce mortality and hospitalisation. Pilot data from our clinic in 25 patients with a pacemaker and CHF, show that optimised medical therapy can lead to similar improvements in cardiac function as in CHF patients without a pacemaker.
The present project therefore includes three distinct, but closely related, work packages which will answer three questions;
- in patients receiving their first pacemaker, which clinical and pacing variables predict short, medium and long-term complications and is it therefore feasible, safe and cost-effective to individualise follow-up intervals;
- can we confirm and validate our previous observation that a model consisting of simple clinical and pacing variables identifies pacemaker patients at higher risk for cardiac dysfunction during a pacemaker-follow-up appointment and;
- does applying our risk model with subsequent optimisation of medication and pacemaker programming within a multidisciplinary heart failure service in those with heart failure lead to cost effective and clinically relevant reductions in mortality and hospitalisation?
- Conditions
- Pacemaker Complication, Congestive Heart Failure
- Being tested
- Enhanced standard management, Optimised heart failure management, Standard management
- Keywords
- Pacemaker, heart failure, hospitalisation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced standard managementOther
Echocardiogram followed by letter to GP about results.
Optimised heart failure managementOther
Echocardiogram followed by referral to comprehensive heart failure service for those with left ventricular dysfunction
Standard managementOther
Usual care
| Study group | Role | What they receive |
|---|---|---|
| Standard management | Placebo comparator | No echocardiogram Receives: Other: Standard management |
| Enhanced standard management | Active comparator | Echocardiogram performed, with results to GP Receives: Other: Enhanced standard management |
| Optimised heart failure management | Active comparator | Echocardiogram, followed by referral to comprehensive heart failure program for those with left ventricular dysfunction Receives: Other: Optimised heart failure management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined hospitalisation and mortality
Measured: 3 years
Secondary outcomes (1)
Predictors of complications from pacemaker implantation
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2013 (estimated)
- Study start1 Aug 2013
- Primary completion1 Oct 2017
- Study completion28 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pacemaker ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,793 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Responsible party
- Principal investigator, KK Witte, University of Leeds
- Investigators
- Klaus K Witte, MD, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819662
- Sponsor's protocol ID
- NIHR-CS-012-032
- Acronym
- OPT-pace
- Status last verified
- Dec 2018
- First submitted
- 24 Mar 2013
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Paton MF, Gierula J, Jamil HA, Straw S, Lowry JE, Byrom R, Slater TA, Fellows AM, Gillott RG, Chumun H, Smith P, Cubbon RM, Stocken DD, Kearney MT, Witte KK. Echocardiographic screening for heart failure and optimization of the care pathway for individuals with pacemakers: a randomized controlled trial. Nat Med. 2024 Nov;30(11):3303-3309. doi: 10.1038/s41591-024-03265-3. Epub 2024 Sep 19.
PubMed 39300290Paton MF, Gierula J, Jamil HA, Lowry JE, Byrom R, Gillott RG, Chumun H, Cubbon RM, Cairns DA, Stocken DD, Kearney MT, Witte KK. Optimising pacemaker therapy and medical therapy in pacemaker patients for heart failure: protocol for the OPT-PACE randomised controlled trial. BMJ Open. 2019 Jul 17;9(7):e028613. doi: 10.1136/bmjopen-2018-028613.
PubMed 31320354
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stratified Management of Patients With Pacemakers
- ClinicalTrials.gov ID
- NCT01819662
- Acronym / sponsor ID
- OPT-pace / NIHR-CS-012-032
- Conditions
- Pacemaker Complication, Congestive Heart Failure
- Keywords
- Pacemaker, heart failure, hospitalisation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,793 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom
- Study start
- 1 Aug 2013 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 28 Feb 2019 (estimated)
- First posted
- 27 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 back-up. Each visit costs around £200 such that pacemaker follow-up cost the NHS around £50million per year. 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.
Our study 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.
Detailed description
Permanent pacemaker implantation is a safe, life-prolonging and cost-effective treatment for bradycardia. An estimated 300,000 people in the UK have a pacemaker and there are 36,000 new implants per year. Complications from pacemaker implantation occur in 5-15% of patients, mostly in the first six weeks. After six months new problems are very rare. Clinic follow-up of patients with a PPM usually occurs at six weeks, three months and then annually to monitor battery performance. Reprogramming is rarely required, and batteries reliably last at least five years. The tariff for pacemaker follow-up is £200 costing the National Health Service (NHS) £50 million per year.
The commonest and most under-recognised long-term complication of pacemaker implantation is pacemaker-related chronic heart failure (CHF) due to left ventricular systolic dysfunction, seen in up to 50% of patients. Published data examining the incidence and associations of pacemaker-related cardiac dysfunction consist of retrospective cross-sectional analyses or data taken from other studies rather than a-priori planned analyses. Our unique pilot data in almost 500 patients show that cardiac dysfunction is present in 40% of all pacemaker patients and confirm previous suggestions that it is more common in patients with an underlying predisposition, for example cardiovascular co-morbidities (including diabetes mellitus), with high rates of pacing and atrial fibrillation. Our data also demonstrate that patients with cardiac dysfunction and a pacemaker are not usually taking optimal medical therapy for their heart failure and suffer a 13% annual combined heart failure hospitalisation or death rate (compared to 6% in pacemaker patients without cardiac dysfunction, and ~8% in patients with CHF attending the Leeds Integrated Heart Failure Service). However, since patients with pacemakers were often excluded from the large studies of medical (and device) therapy of CHF, it is unclear whether optimisation of medical (and pacemaker) therapy in patients with pacemaker-related cardiac dysfunction can reduce mortality and hospitalisation. Pilot data from our clinic in 25 patients with a pacemaker and CHF, show that optimised medical therapy can lead to similar improvements in cardiac function as in CHF patients without a pacemaker.
The present project therefore includes three distinct, but closely related, work packages which will answer three questions;
- in patients receiving their first pacemaker, which clinical and pacing variables predict short, medium and long-term complications and is it therefore feasible, safe and cost-effective to individualise follow-up intervals;
- can we confirm and validate our previous observation that a model consisting of simple clinical and pacing variables identifies pacemaker patients at higher risk for cardiac dysfunction during a pacemaker-follow-up appointment and;
- does applying our risk model with subsequent optimisation of medication and pacemaker programming within a multidisciplinary heart failure service in those with heart failure lead to cost effective and clinically relevant reductions in mortality and hospitalisation?
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard management | Placebo comparator | Other: Standard managementNo echocardiogram |
| Enhanced standard management | Active comparator | Other: Enhanced standard managementEchocardiogram performed, with results to GP |
| Optimised heart failure management | Active comparator | Other: Optimised heart failure managementEchocardiogram, followed by referral to comprehensive heart failure program for those with left ventricular dysfunction |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pacemaker implantation
Key exclusion criteria (1 listed)
- Dementia, unwilling to fill in quality of life questionnaires, unwilling to sign consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced standard managementEchocardiogram followed by letter to GP about results. | Other | Enhanced standard management |
| Optimised heart failure managementEchocardiogram followed by referral to comprehensive heart failure service for those with left ventricular dysfunction | Other | Optimised heart failure management |
| Standard managementUsual care | Other | Standard management |
Primary outcome
Combined hospitalisation and mortality
Time frame: 3 years
1 secondary outcome
Predictors of complications from pacemaker implantation
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Derived from this study: PubMed 39300290Paton MF, Gierula J, Jamil HA, Straw S, Lowry JE, Byrom R, Slater TA, Fellows AM, Gillott RG, Chumun H, Smith P, Cubbon RM, Stocken DD, Kearney MT, Witte KK. Echocardiographic screening for heart failure and optimization of the care pathway for individuals with pacemakers: a randomized controlled trial. Nat Med. 2024 Nov;30(11):3303-3309. doi: 10.1038/s41591-024-03265-3. Epub 2024 Sep 19.
- Derived from this study: PubMed 31320354Paton MF, Gierula J, Jamil HA, Lowry JE, Byrom R, Gillott RG, Chumun H, Cubbon RM, Cairns DA, Stocken DD, Kearney MT, Witte KK. Optimising pacemaker therapy and medical therapy in pacemaker patients for heart failure: protocol for the OPT-PACE randomised controlled trial. BMJ Open. 2019 Jul 17;9(7):e028613. doi: 10.1136/bmjopen-2018-028613.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaus K Witte, MD principal investigator
University of Leeds
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Enhanced standard management, Optimised heart failure management and Standard management in people with Pacemaker Complication and Congestive Heart Failure, run by University of Leeds at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined hospitalisation and mortality (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01819662, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018; AzTrials last refreshed its copy on 27 Oct 2026.