NCT03917914

Preventing Adverse Cardiac Events in COPD

Preventing Adverse Cardiac Events in Chronic Obstructive Pulmonary Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 280 (actual)
• Sponsor: The George Institute · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

A double-blind, randomised controlled trial in participants with COPD to assess the efficacy of proactive treatment of cardiac risk in people with COPD. We hypothesise that treating known and undiagnosed CVD in COPD participants will improve both cardiac and respiratory outcomes.

Detailed description

Chronic Obstructive Pulmonary Disease (COPD) is the third leading cause of global health-related morbidity and mortality. Heart disease in COPD is a known but neglected comorbidity and cardiovascular disease (CVD) accounts for 30-50% of deaths in COPD participants. Studies repeatedly show that CVD in COPD participants is under-recognised and under-treated yet participants with COPD are frequently excluded from clinical trials of drugs which reduce cardiac morbidity and mortality. This has led to under-treatment of CVD in COPD participants. A particular concern is low use of β-blockers. These have previously been considered to be contra-indicated in COPD and no RCTs have been conducted in this population. There is now observational evidence that cardioselective β-blockers are safe and may improve mortality, but this data is limited to retrospective analyses of cohorts of COPD participants. Contrary to previous concerns, retrospective analyses also suggest that cardioselective β-blockers may reduce the risk of COPD exacerbations. The proposed study will focus on treating CVD in COPD participants to reduce mortality and morbidity. The study will be conducted in 23 sites in Australia, New Zealand, India and Sri Lanka. Participants with COPD will be randomised to one of two treatment arms in addition to receiving usual care for their COPD over the study duration of 24 months.

Conditions

• Chronic Obstructive Pulmonary Disease
• Cardiovascular Diseases

Interventions

Type	Name	Description
DRUG	Bisoprolol	As in arm description
DRUG	Placebo Oral Tablet	As in arm description

Timeline

• Start date: 2020-06-30
• Primary completion: 2025-03-31
• Completion: 2025-03-31
• First posted: 2019-04-17
• Last updated: 2025-05-16

Locations

24 sites across 4 countries: Australia, India, New Zealand, Sri Lanka