Optimising pacemaker therapy and medical therapy in pacemaker patients for heart failure: protocol for the OPT-PACE randomised controlled trial
Introduction Permanent artificial pacemaker implantation is a safe and effective treatment for bradycardia and is associated with extended longevity and improved quality of life. However, the most common long-term complication of standard pacemaker therapy is pacemaker-associated heart failure. Pace...
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| Format: | Article |
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BMJ Publishing Group
2019-07-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/9/7/e028613.full |
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| author | Deborah D Stocken Klaus K Witte Judith E Lowry Rowena Byrom Richard G Gillott Hemant Chumun Richard M Cubbon David A Cairns Mark T Kearney |
| author_facet | Deborah D Stocken Klaus K Witte Judith E Lowry Rowena Byrom Richard G Gillott Hemant Chumun Richard M Cubbon David A Cairns Mark T Kearney |
| author_sort | Deborah D Stocken |
| collection | DOAJ |
| description | Introduction Permanent artificial pacemaker implantation is a safe and effective treatment for bradycardia and is associated with extended longevity and improved quality of life. However, the most common long-term complication of standard pacemaker therapy is pacemaker-associated heart failure. Pacemaker follow-up is potentially an opportunity to screen for heart failure to assess and optimise patient devices and medical therapy.Methods and analysis The study is a multicentre, phase-3 randomised trial. The 1200 participants will be people who have a permanent pacemaker for bradycardia for at least 12 months, randomly assigned to undergo a transthoracic echocardiogram with their pacemaker check, thereby tailoring their management directed by left ventricular function or the pacemaker check alone, continuing with routine follow-up. The primary outcome measure is time to all-cause mortality or heart failure hospitalisation. Secondary outcomes include external validation of our risk stratification model to predict onset of heart failure and quality of life assessment.Ethics and Dissemination The trial design and protocol have received national ethical approval (12/YH/0487). The results of this randomised trial will be published in international peer-reviewed journals, communicated to healthcare professionals and patient involvement groups and highlighted using social media campaigns.Trial registration number NCT01819662. |
| format | Article |
| id | doaj-art-4e2b64fc5e70468bb198707ad90ff156 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2019-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-4e2b64fc5e70468bb198707ad90ff1562024-11-23T18:05:08ZengBMJ Publishing GroupBMJ Open2044-60552019-07-019710.1136/bmjopen-2018-028613Optimising pacemaker therapy and medical therapy in pacemaker patients for heart failure: protocol for the OPT-PACE randomised controlled trialDeborah D Stocken0Klaus K Witte1Judith E Lowry2Rowena Byrom3Richard G Gillott4Hemant Chumun5Richard M Cubbon6David A Cairns7Mark T Kearney84 Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, UK1 Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK1 Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK1 Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK2 Department of Cardiology, Leeds Teaching Hospitals NHS Trust, Leeds, UK1 Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK1 Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UKLeeds Cancer Research UK Clinical Trials Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK1 Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UKIntroduction Permanent artificial pacemaker implantation is a safe and effective treatment for bradycardia and is associated with extended longevity and improved quality of life. However, the most common long-term complication of standard pacemaker therapy is pacemaker-associated heart failure. Pacemaker follow-up is potentially an opportunity to screen for heart failure to assess and optimise patient devices and medical therapy.Methods and analysis The study is a multicentre, phase-3 randomised trial. The 1200 participants will be people who have a permanent pacemaker for bradycardia for at least 12 months, randomly assigned to undergo a transthoracic echocardiogram with their pacemaker check, thereby tailoring their management directed by left ventricular function or the pacemaker check alone, continuing with routine follow-up. The primary outcome measure is time to all-cause mortality or heart failure hospitalisation. Secondary outcomes include external validation of our risk stratification model to predict onset of heart failure and quality of life assessment.Ethics and Dissemination The trial design and protocol have received national ethical approval (12/YH/0487). The results of this randomised trial will be published in international peer-reviewed journals, communicated to healthcare professionals and patient involvement groups and highlighted using social media campaigns.Trial registration number NCT01819662.https://bmjopen.bmj.com/content/9/7/e028613.full |
| spellingShingle | Deborah D Stocken Klaus K Witte Judith E Lowry Rowena Byrom Richard G Gillott Hemant Chumun Richard M Cubbon David A Cairns Mark T Kearney Optimising pacemaker therapy and medical therapy in pacemaker patients for heart failure: protocol for the OPT-PACE randomised controlled trial BMJ Open |
| title | Optimising pacemaker therapy and medical therapy in pacemaker patients for heart failure: protocol for the OPT-PACE randomised controlled trial |
| title_full | Optimising pacemaker therapy and medical therapy in pacemaker patients for heart failure: protocol for the OPT-PACE randomised controlled trial |
| title_fullStr | Optimising pacemaker therapy and medical therapy in pacemaker patients for heart failure: protocol for the OPT-PACE randomised controlled trial |
| title_full_unstemmed | Optimising pacemaker therapy and medical therapy in pacemaker patients for heart failure: protocol for the OPT-PACE randomised controlled trial |
| title_short | Optimising pacemaker therapy and medical therapy in pacemaker patients for heart failure: protocol for the OPT-PACE randomised controlled trial |
| title_sort | optimising pacemaker therapy and medical therapy in pacemaker patients for heart failure protocol for the opt pace randomised controlled trial |
| url | https://bmjopen.bmj.com/content/9/7/e028613.full |
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