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Preventing adverse cardiac events (PACE) in chronic obstructive pulmonary disease (COPD): study protocol for a
Allison Martin1,2, Robert J Hancox3, Catherina L Chang4
1The George Institute for Global Health, Newtown, New South Wales, Australia ahumphries@georgeinstitute.org.au.
Insights
This study investigates if cardioselective beta-blockers are safe and beneficial for patients with chronic obstructive pulmonary disease (COPD). The trial aims to determine if these medications reduce mortality and cardiac/respiratory issues in COPD patients.
Area of Science:
- Cardiology
- Pulmonology
- Clinical Trials
Background:
- Heart disease is a common, overlooked comorbidity in chronic obstructive pulmonary disease (COPD).
- Patients with COPD are often excluded from cardiovascular clinical trials, leading to undertreatment of heart disease.
- Cardioselective beta-blockers are underused in COPD despite observational data suggesting safety and potential mortality benefits.
Purpose of the Study:
- To determine if cardioselective beta-blocker treatment is safe and beneficial in individuals with moderate to severe COPD.
- To investigate the impact of cardioselective beta-blockers on mortality and cardiac and respiratory morbidity in COPD patients.
Main Methods:
- A double-blind, randomized controlled trial involving 1164 participants with moderate to severe COPD.
- Participants aged 40-85 years will receive either bisoprolol (1.25-5mg daily) or a placebo for 24 months, alongside usual COPD care.
- Inclusion criteria include symptomatic COPD, postbronchodilator FEV1 between 30-70% predicted, and a history of exacerbations.
Main Results:
- This section is to be filled once the study is completed and results are available.
Conclusions:
- This section is to be filled once the study is completed and results are available.
Introduction:
Heart disease in chronic obstructive pulmonary disease (COPD) is a common but neglected comorbidity. Patients with COPD are frequently excluded from clinical trials of treatments aimed at reducing cardiac morbidity and mortality, which has led to undertreatment of cardiovascular disease in patients with COPD. A particular concern in COPD is the underuse of beta (β)-blockers. There is observational evidence that cardioselective β-blockers are safe and may even reduce mortality risk in COPD, although some evidence is conflicting. There is an urgent need to answer the research question: Are cardioselective β-blockers safe and of benefit in people with moderately severe COPD? The proposed study will investigate whether cardioselective β-blocker treatment in patients with COPD reduces mortality and cardiac and respiratory morbidity.
Methods And Analyses:
This is a double-blind, randomised controlled trial to be conducted in approximately 26 sites in Australia, New Zealand, India, Sri Lanka and other countries as required. Participants with COPD will be randomised to either bisoprolol once daily (range 1.25-5 mg, dependent on tolerated dose) or matched placebo, in addition to receiving usual care for their COPD over the study duration of 24 months.The study will enrol 1164 participants with moderate to severe COPD, aged 40-85 years. Participants will be symptomatic from their COPD and have a postbronchodilator forced expiratory volume in 1 s (FEV1) ≥30% and ≤70% predicted and a history of at least one exacerbation requiring systemic corticosteroids, antibiotics or both in the prior 24 months.
Ethics And Dissemination:
The study protocol has been approved by the Sydney Local Health District Human Research Ethics Committee at The Concord Repatriation General Hospital.
Trial Registration Numbers:
NCT03917914; CTRI/2020/08/027322.
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