Preventing Adverse Cardiac Events in Chronic Obstructive Pulmonary Disease
- Conditions
- Health Condition 1: J96-J99- Other diseases of the respiratory system
- Registration Number
- CTRI/2020/08/027322
- Lead Sponsor
- George Institute for Global Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Have provided written informed consent
2. Have COPD defined by 2019 GOLD diagnostic criteria1
3. Aged =40 and =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 OCS, antibiotics, or both
7. If taking maintenance OCS, dosage is stable and =10 mg daily for 4 weeks prior to randomisation
8. Resting SBP =100mmHg
9. BP and spirometry criteria must be met after the test dose of bisoprolol of 1.25mg
Participants will be ineligible for the study if any of the following are present:
1. Concurrent therapy with any other ß-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 ß-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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to a composite outcome (includes any) of <br/ ><br>a. All-cause mortality Hospitalisation for COPD <br/ ><br> exacerbation <br/ ><br>b. or primary cardiac cause (ischaemia, arrhythmia or <br/ ><br> heart failure [HF]) <br/ ><br>c. Major Adverse Cardiovascular Event (MACE) <br/ ><br>d. Moderate COPD exacerbation <br/ ><br>e. Decrease in FEV1 <br/ ><br>f. Mild COPD exacerbation <br/ ><br>g. QOL and symptom burden <br/ ><br>Timepoint: Baseline to 24 Months for all events <br/ ><br>
- Secondary Outcome Measures
Name Time Method