Key result
The OPT-PACE trial is a protocol for a randomized controlled trial designed to evaluate whether echocardiogram-directed pacemaker optimization reduces all-cause mortality or heart failure hospitalization.
Why the study?
The most common long-term complication of standard pacemaker therapy is pacemaker-associated heart failure, and pacemaker follow-up presents a potential opportunity to screen for heart failure and optimize device and medical therapy.
Does transthoracic echocardiogram-guided management reduce all-cause mortality or heart failure hospitalisation in patients with a permanent pacemaker for bradycardia?
RCT (n=1,200)
Single-blind
1:1
Yes
Does transthoracic echocardiogram-guided management reduce all-cause mortality or heart failure hospitalisation in patients with a permanent pacemaker for bradycardia?
This protocol outlines a trial to determine if routine echocardiography during pacemaker follow-up improves clinical outcomes by optimizing heart failure management.
Answers are grounded in this paper and cite their sources.
Trial underway to test echo-guided management in pacemaker patients; leaves open impact on mortality or HF hospitalization.
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.
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Paton et al. (2019) conducted an RCT in Bradycardia with permanent pacemaker (n=1,200). Echocardiogram-directed pacemaker optimization and medical therapy vs. Standard care (routine pacemaker follow-up) was evaluated on Time to first event of all-cause mortality or heart failure hospitalisation. The OPT-PACE trial is a protocol for a randomized controlled trial designed to evaluate whether echocardiogram-directed pacemaker optimization reduces all-cause mortality or heart failure hospitalization.
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