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Optimising pacemaker therapy and medical therapy in pacemaker patients for heart failure: protocol for the OPT-PACE randomised controlled trial
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| Zeitschriftentitel: | BMJ Open |
|---|---|
| Personen und Körperschaften: | , , , , , , , , , , , |
| In: | BMJ Open, 9, 2019, 7, S. e028613 |
| Format: | E-Article |
| Sprache: | Englisch |
| veröffentlicht: |
BMJ
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| Schlagwörter: |
| author_facet |
Paton, Maria F Gierula, John Jamil, Haqeel A Lowry, Judith E Byrom, Rowena Gillott, Richard G Chumun, Hemant Cubbon, Richard M Cairns, David A Stocken, Deborah D Kearney, Mark T Witte, Klaus K Paton, Maria F Gierula, John Jamil, Haqeel A Lowry, Judith E Byrom, Rowena Gillott, Richard G Chumun, Hemant Cubbon, Richard M Cairns, David A Stocken, Deborah D Kearney, Mark T Witte, Klaus K |
|---|---|
| author |
Paton, Maria F Gierula, John Jamil, Haqeel A Lowry, Judith E Byrom, Rowena Gillott, Richard G Chumun, Hemant Cubbon, Richard M Cairns, David A Stocken, Deborah D Kearney, Mark T Witte, Klaus K |
| spellingShingle |
Paton, Maria F Gierula, John Jamil, Haqeel A Lowry, Judith E Byrom, Rowena Gillott, Richard G Chumun, Hemant Cubbon, Richard M Cairns, David A Stocken, Deborah D Kearney, Mark T Witte, Klaus K BMJ Open Optimising pacemaker therapy and medical therapy in pacemaker patients for heart failure: protocol for the OPT-PACE randomised controlled trial General Medicine |
| author_sort |
paton, maria f |
| spelling |
Paton, Maria F Gierula, John Jamil, Haqeel A Lowry, Judith E Byrom, Rowena Gillott, Richard G Chumun, Hemant Cubbon, Richard M Cairns, David A Stocken, Deborah D Kearney, Mark T Witte, Klaus K 2044-6055 2044-6055 BMJ General Medicine http://dx.doi.org/10.1136/bmjopen-2018-028613 <jats:sec><jats:title>Introduction</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Methods and analysis</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Ethics and Dissemination</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Trial registration number</jats:title><jats:p><jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="NCT01819662" ext-link-type="clintrialgov">NCT01819662</jats:ext-link>.</jats:p></jats:sec> Optimising pacemaker therapy and medical therapy in pacemaker patients for heart failure: protocol for the OPT-PACE randomised controlled trial BMJ Open |
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| title |
Optimising pacemaker therapy and medical therapy in pacemaker patients for heart failure: protocol for the OPT-PACE randomised controlled trial |
| title_unstemmed |
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 |
| topic |
General Medicine |
| url |
http://dx.doi.org/10.1136/bmjopen-2018-028613 |
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2019 |
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e028613 |
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<jats:sec><jats:title>Introduction</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Methods and analysis</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Ethics and Dissemination</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Trial registration number</jats:title><jats:p><jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="NCT01819662" ext-link-type="clintrialgov">NCT01819662</jats:ext-link>.</jats:p></jats:sec> |
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| author | Paton, Maria F, Gierula, John, Jamil, Haqeel A, Lowry, Judith E, Byrom, Rowena, Gillott, Richard G, Chumun, Hemant, Cubbon, Richard M, Cairns, David A, Stocken, Deborah D, Kearney, Mark T, Witte, Klaus K |
| author_facet | Paton, Maria F, Gierula, John, Jamil, Haqeel A, Lowry, Judith E, Byrom, Rowena, Gillott, Richard G, Chumun, Hemant, Cubbon, Richard M, Cairns, David A, Stocken, Deborah D, Kearney, Mark T, Witte, Klaus K, Paton, Maria F, Gierula, John, Jamil, Haqeel A, Lowry, Judith E, Byrom, Rowena, Gillott, Richard G, Chumun, Hemant, Cubbon, Richard M, Cairns, David A, Stocken, Deborah D, Kearney, Mark T, Witte, Klaus K |
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| description | <jats:sec><jats:title>Introduction</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Methods and analysis</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Ethics and Dissemination</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Trial registration number</jats:title><jats:p><jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="NCT01819662" ext-link-type="clintrialgov">NCT01819662</jats:ext-link>.</jats:p></jats:sec> |
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| spelling | Paton, Maria F Gierula, John Jamil, Haqeel A Lowry, Judith E Byrom, Rowena Gillott, Richard G Chumun, Hemant Cubbon, Richard M Cairns, David A Stocken, Deborah D Kearney, Mark T Witte, Klaus K 2044-6055 2044-6055 BMJ General Medicine http://dx.doi.org/10.1136/bmjopen-2018-028613 <jats:sec><jats:title>Introduction</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Methods and analysis</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Ethics and Dissemination</jats:title><jats:p>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.</jats:p></jats:sec><jats:sec><jats:title>Trial registration number</jats:title><jats:p><jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" xlink:href="NCT01819662" ext-link-type="clintrialgov">NCT01819662</jats:ext-link>.</jats:p></jats:sec> Optimising pacemaker therapy and medical therapy in pacemaker patients for heart failure: protocol for the OPT-PACE randomised controlled trial BMJ Open |
| spellingShingle | Paton, Maria F, Gierula, John, Jamil, Haqeel A, Lowry, Judith E, Byrom, Rowena, Gillott, Richard G, Chumun, Hemant, Cubbon, Richard M, Cairns, David A, Stocken, Deborah D, Kearney, Mark T, Witte, Klaus K, BMJ Open, Optimising pacemaker therapy and medical therapy in pacemaker patients for heart failure: protocol for the OPT-PACE randomised controlled trial, General Medicine |
| 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 |
| title_unstemmed | Optimising pacemaker therapy and medical therapy in pacemaker patients for heart failure: protocol for the OPT-PACE randomised controlled trial |
| topic | General Medicine |
| url | http://dx.doi.org/10.1136/bmjopen-2018-028613 |