Preventing Adverse Cardiac Events in COPD

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The George Institute
• Treatments: Bisoprolol

Criteria

Inclusion Criteria:

Participants will be eligible for this study if they qualify on all of the following:

1. Have provided written informed consent

2. Have COPD defined by the 2019 Global Initiative for Chronic Obstructive Lung Disease (GOLD) diagnostic criteria

3. Aged 40-85 years

4. FEV1 ≥30% and ≤70% predicted post-bronchodilator

5. FEV1/FVC <0.7 post-bronchodilator

6. Have had a COPD exacerbation in the previous 12 months requiring oral corticosteroid, antibiotics, or both

7. If taking maintenance OCS, dosage is stable and ≤10mg daily for 4 weeks prior to randomisation

8. Resting SBP ≥100mmHg

9. SBP and spirometry criteria must be met after the test dose of bisoprolol of 1.25mg

10. (New Zealand only) A history of cardiovascular disease, including heart failure, ischaemic heart disease, tachyarrhythmias, and hypertension

Exclusion Criteria:

Participants will be ineligible for the study if they have any of the following:

1. Concurrent therapy with any other β-blocker

2. Resting HR <60bpm

3. Unstable left HF (i.e. symptomatic and/or necessary change in management in the last 12 weeks, or in clinicians' opinion)

4. Clinically significant pulmonary hypertension, which in the investigator's opinion would be a contraindication for β-blocker therapy

5. Severe end-stage peripheral vascular disease

6. 2nd or 3rd degree heart block

7. Currently using or have been prescribed LTOT or resting saturated oxygen level <90% when stable

8. Expected survival is less than 12 months, or in the investigator's opinion, the person has such unstable disease (of any type) that maintaining 12 months' participation would be unlikely

9. Clinical instability since a MACE in the previous 12 weeks

10. Lower respiratory tract infection or AECOPD within the last 8 weeks

11. COPD not clinically stable as determined by the investigator

12. In the clinician's view, have asthma-COPD overlap or co-existent asthma are present; or an improvement in FEV1 ≥400mL post-bronchodilator is observed on two occasions

13. Females of child-bearing age and capability who are pregnant or breastfeeding or those in this group not using adequate birth control

14. Coexistent illness which precludes participation in the study (poorly controlled diabetes, active malignancy)

15. Severe end-stage liver disease defined by INR>1.3 and albumin<30g/L or portal hypertension/ascites

16. High chance in the view of the treating physician that the potential participant will not adhere to study requirements