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Optimising pacemaker therapy and medical therapy in pacemaker patients for heart failure: protocol for the OPT-PACE randomised controlled trial.


ABSTRACT: 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.

SUBMITTER: Paton MF 

PROVIDER: S-EPMC6661620 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Optimising pacemaker therapy and medical therapy in pacemaker patients for heart failure: protocol for the OPT-PACE randomised controlled trial.

Paton Maria F MF   Gierula John J   Jamil Haqeel A HA   Lowry Judith E JE   Byrom Rowena R   Gillott Richard G RG   Chumun Hemant H   Cubbon Richard M RM   Cairns David A DA   Stocken Deborah D DD   Kearney Mark T MT   Witte Klaus K KK  

BMJ open 20190717 7


<h4>Introduction</h4>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.<h4>Methods and analysis</h4>The study is a multicentre, ph  ...[more]

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