Optimised Pacing Program (OPT-pace)
Primary Purpose
Pacemaker Complication, Congestive Heart Failure
Status
Unknown status
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Enhanced standard management
Optimised heart failure management
Standard management
Sponsored by
About this trial
This is an interventional diagnostic trial for Pacemaker Complication focused on measuring Pacemaker, heart failure, hospitalisation
Eligibility Criteria
Inclusion Criteria:
- Pacemaker implantation
Exclusion Criteria:
- Dementia, unwilling to fill in quality of life questionnaires, unwilling to sign consent form
Sites / Locations
- Bradford Hospitals NHS Foundation Trust
- Harrogate Hospital Foundation Trust
- Leeds General Infirmary
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Standard management
Enhanced standard management
Optimised heart failure management
Arm Description
No echocardiogram
Echocardiogram performed, with results to GP
Echocardiogram, followed by referral to comprehensive heart failure program for those with left ventricular dysfunction
Outcomes
Primary Outcome Measures
Combined hospitalisation and mortality
Secondary Outcome Measures
Predictors of complications from pacemaker implantation
Full Information
NCT ID
NCT01819662
First Posted
March 24, 2013
Last Updated
December 18, 2018
Sponsor
University of Leeds
Collaborators
National Institute for Health Research, United Kingdom
1. Study Identification
Unique Protocol Identification Number
NCT01819662
Brief Title
Optimised Pacing Program
Acronym
OPT-pace
Official Title
Stratified Management of Patients With Pacemakers
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2013 (Actual)
Primary Completion Date
October 1, 2017 (Actual)
Study Completion Date
February 28, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leeds
Collaborators
National Institute for Health Research, United Kingdom
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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. 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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pacemaker Complication, Congestive Heart Failure
Keywords
Pacemaker, heart failure, hospitalisation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
1793 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard management
Arm Type
Placebo Comparator
Arm Description
No echocardiogram
Arm Title
Enhanced standard management
Arm Type
Active Comparator
Arm Description
Echocardiogram performed, with results to GP
Arm Title
Optimised heart failure management
Arm Type
Active Comparator
Arm Description
Echocardiogram, followed by referral to comprehensive heart failure program for those with left ventricular dysfunction
Intervention Type
Other
Intervention Name(s)
Enhanced standard management
Intervention Description
Echocardiogram followed by letter to GP about results.
Intervention Type
Other
Intervention Name(s)
Optimised heart failure management
Intervention Description
Echocardiogram followed by referral to comprehensive heart failure service for those with left ventricular dysfunction
Intervention Type
Other
Intervention Name(s)
Standard management
Intervention Description
Usual care
Primary Outcome Measure Information:
Title
Combined hospitalisation and mortality
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Predictors of complications from pacemaker implantation
Time Frame
3 years
Other Pre-specified Outcome Measures:
Title
Predictors of cardiac dysfunction in pacemaker patients
Description
Who will develop cardiac dysfunction after permanent pacemaker implantation? Who under follow-up has cardiac dysfunction and how can it be identified?
Time Frame
1-3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pacemaker implantation
Exclusion Criteria:
Dementia, unwilling to fill in quality of life questionnaires, unwilling to sign consent form
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus K Witte, MD
Organizational Affiliation
University of Leeds
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bradford Hospitals NHS Foundation Trust
City
Bradford
State/Province
Yorkshire
Country
United Kingdom
Facility Name
Harrogate Hospital Foundation Trust
City
Harrogate
State/Province
Yorkshire
Country
United Kingdom
Facility Name
Leeds General Infirmary
City
Leeds
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
31320354
Citation
Paton 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.
Results Reference
derived
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Optimised Pacing Program
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