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NCT03917914CompletedPhase 3

Preventing Adverse Cardiac Events in COPD

Preventing Adverse Cardiac Events in Chronic Obstructive Pulmonary Disease

Source: ClinicalTrials.gov · Last updated 16 May 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
280 (actual)
First submitted
10 Apr 2019
Start date
30 Jun 2020
Primary completion date
31 Mar 2025
Lead sponsor
The George Institute
Diseases
COPD
NCT number
NCT03917914

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 280
  • From 30 Jun 2020 to the primary completion date, 31 Mar 2025
  • 24 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concurrent therapy with any other β-blocker
  • Currently using or have been prescribed LTOT or resting saturated oxygen level \<90% when stable
  • Clinical instability since a MACE in the previous 12 weeks

Other illness

  • Clinically significant pulmonary hypertension, which in the investigator's opinion would be a contraindication for β-blocker therapy
  • Severe end-stage peripheral vascular disease
  • 2nd or 3rd degree heart block
  • 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
  • Lower respiratory tract infection or AECOPD within the last 8 weeks
  • Coexistent illness which precludes participation in the study (poorly controlled diabetes, active malignancy)

Lab values

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

Age

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

Other

  • Participants will be ineligible for the study if they have any of the following:
  • Resting HR \<60bpm
  • Unstable left HF (i.e. symptomatic and/or necessary change in management in the last 12 weeks, or in clinicians' opinion)
  • COPD not clinically stable as determined by the investigator
  • 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
  • High chance in the view of the treating physician that the potential participant will not adhere to study requirements

Who the study is looking for

  • Participants will be eligible for this study if they qualify on all of the following:
  • Have provided written informed consent
  • Have COPD defined by the 2019 Global Initiative for Chronic Obstructive Lung Disease (GOLD) diagnostic criteria
  • Aged 40-85 years
  • FEV1 ≥30% and ≤70% predicted post-bronchodilator
  • FEV1/FVC \<0.7 post-bronchodilator
  • Have had a COPD exacerbation in the previous 24 months requiring oral corticosteroid, antibiotics, or both
  • If taking maintenance OCS, dosage is stable and ≤10mg daily for 4 weeks prior to randomisation
  • Resting SBP ≥100mmHg
  • SBP and spirometry criteria must be met after the test dose of bisoprolol of 1.25mg
  • (New Zealand only) A history of cardiovascular disease, including heart failure, ischaemic heart disease, tachyarrhythmias, and hypertension

Age in the registry: 40 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (24)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Princess Alexandra Hospital
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BrisbaneAustraliaUnknown status
Prince Charles Hospital
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BrisbaneAustraliaUnknown status
Campbelltown Hospital
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CampbelltownAustraliaUnknown status
Liverpool Hospital
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LiverpoolAustraliaUnknown status
Fiona Stanley Hospital
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MurdochAustraliaUnknown status
John Hunter Hospital & Hunter Medical Research Institute
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NewcastleAustraliaUnknown status
TrialsWest Pty Ltd
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PerthAustraliaUnknown status
Institute for Respiratory Health
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PerthAustraliaUnknown status
Gold Coast University Hospital
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SouthportAustraliaUnknown status
Concord Repatriation General Hospital
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SydneyAustraliaUnknown status
Westmead Hospital
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SydneyAustraliaUnknown status
St. John's Medical College Hospital
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BangaloreIndiaUnknown status
Postgraduate Institute of Medical Education and Research
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ChandigarhIndiaUnknown status
All India Institute of Medical Sciences
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New DelhiIndiaUnknown status
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences
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RohtakIndiaUnknown status
Central Chest Clinic - Borella
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ColomboSri LankaUnknown status
Central Chest Clinic
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ColomboSri LankaUnknown status
Kandy National Hospital
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KandySri LankaUnknown status
National Institute of Respiratory Diseases
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WelisaraSri LankaUnknown status
Middlemore Hospital
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AucklandNew ZealandUnknown status
University of Otago
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ChristchurchNew ZealandUnknown status
Dunedin Hospital
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DunedinNew ZealandUnknown status
Waikato Hospital
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HamiltonNew ZealandUnknown status
Medical Research Institute of New Zealand
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WellingtonNew ZealandUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.