Chronic Obstructive Pulmonary DiseasePhase 3PACE in COPDNCT03917914
Preventing Adverse Cardiac Events in COPD
A Phase 3 study testing Bisoprolol in people with Chronic Obstructive Pulmonary Disease and Cardiovascular Diseases, run by The George Institute at 24 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Cardiovascular Diseases
- What is being tested?
- Bisoprolol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 24 sitesin 4 countries
- Study dates
- 30 Jun 2020to 31 Mar 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- Participants will be ineligible for the study if they have any of the following:
- Concurrent therapy with any other β-blocker
- Resting HR <60bpm
- Unstable left HF (i.e. symptomatic and/or necessary change in management in the last 12 weeks, or in clinicians' opinion)
- Clinically significant pulmonary hypertension, which in the investigator's opinion would be a contraindication for β-blocker therapy
- Severe end-stage peripheral vascular disease
Show all 17Show fewer
- 2nd or 3rd degree heart block
- Currently using or have been prescribed LTOT or resting saturated oxygen level <90% when stable
- 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
- Clinical instability since a MACE in the previous 12 weeks
- Lower respiratory tract infection or AECOPD within the last 8 weeks
- 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
- Females of child-bearing age and capability who are pregnant or breastfeeding or those in this group not using adequate birth control
- Coexistent illness which precludes participation in the study (poorly controlled diabetes, active malignancy)
- Severe end-stage liver disease defined by INR>1.3 and albumin<30g/L or portal hypertension/ascites
- High chance in the view of the treating physician that the potential participant will not adhere to study requirements
Trial locations and contacts
24 sites in 4 countries.
24 sites in 4 countries
Australia11 sites
Prince Charles Hospital
Brisbane, Queensland, 4032
Princess Alexandra Hospital
Brisbane, Queensland, 4102
Campbelltown Hospital
Campbelltown, New South Wales, 2560
Liverpool Hospital
Liverpool, New South Wales, 2170
Fiona Stanley Hospital
Murdoch, Washington, 6150
John Hunter Hospital & Hunter Medical Research Institute
Newcastle, New South Wales, 2305
TrialsWest Pty Ltd
Perth, Washington, 6000
Institute for Respiratory Health
Perth, Washington, 6009
Gold Coast University Hospital
Southport, Queensland, 4215
Concord Repatriation General Hospital
Sydney, New South Wales, 2139
Westmead Hospital
Sydney, New South Wales, 2145
New Zealand5 sites
Middlemore Hospital
Auckland, 2025
University of Otago
Christchurch, 8011
Dunedin Hospital
Dunedin, 9054
Waikato Hospital
Hamilton, 3240
Medical Research Institute of New Zealand
Wellington, 6021
India4 sites
St John's Medical College Hospital
Bangalore
Postgraduate Institute of Medical Education and Research
Chandigarh
All India Institute of Medical Sciences
New Delhi
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences
Rohtak, Haryana
Sri Lanka4 sites
Central Chest Clinic - Borella
Colombo
Central Chest Clinic
Colombo
Kandy National Hospital
Kandy
National Institute of Respiratory Diseases
Welisara
About this study
Official title: Preventing Adverse Cardiac Events in Chronic Obstructive Pulmonary Disease
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.
Read the 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.
- Being tested
- Bisoprolol, Placebo Oral Tablet
- Keywords
- COPD, MACE
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BisoprololDrug
As in arm description
Placebo Oral TabletDrug
As in arm description
| Study group | Role | What they receive |
|---|---|---|
| Bisoprolol | Active comparator | 1.25, 2.5 or 5mg of bisoprolol daily Receives: Drug: Bisoprolol |
| Placebo | Placebo comparator | 1.25, 2.5 or 5mg of matched placebo daily Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Composite outcome of the following that will be analysed using a win-ratio apprach according to clinical importance
Measured: Baseline to 24 months
Hospitalisation for COPD exacerbation
Measured: Baseline to 24 months
Hospitalisation for primary cardiac cause (ischaemia, arrhythmia, heart failure or ischaemic stroke)
Measured: Baseline to 24 months
Moderate COPD exacerbation - not hospitalised by treated with oral corticosteroids/antibiotics or both
Measured: Baseline to 24 months
Cardiac Hospitalisation for cardiac cause other than ischemia, arrythmia or heart failure
Measured: Baseline to 24 months
Respiratory hospitalisation for a respiratory cause other than COPD exacerbation
Measured: Baseline to 24 months
Decrease in FEV1 or greatest FEV1% drop - largest decrease in FEV1 from post-bronchodiliator spirometry at baseline
Measured: Baseline to 24 months
Mild COPD exacerbation - treated with increased inhalers/inhaler technique/addition of theophylline
Measured: Baseline to 24 months
Higher SGRQ score (clinically important change >= 4)
Measured: Baseline to 12 and 24 months
Higher CAT score (clinically important change >= 2)
Measured: Baseline to 12 and 24 months
Secondary outcomes (14)
Time to first moderate-severe COPD Exacerbation
Measured: Baseline to 24 months
Severe (hospital admission) COPD exacerbation rate (annualised)
Measured: Baseline to 24 months
Number of events of composite (annualised) cardio-respiratory hospital admissions and MACE
Measured: Baseline to 24 months
Quality of life assessed by St George's Respiratory Questionnaire (SGRQ)
The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction.
Scores are calculated for three domains:
Symptoms, Activity and Impacts (Psycho-social) as well as a total score.
Psychometric testing has demonstrated its repeatability, reliability and validity. Sensitivity has been demonstrated in clinical trials.
A minimum change in score of 4 units was established as clinically relevant after patient and clinician testing. The SGRQ has been used in a range of disease groups including asthma, chronic obstructive pulmonary disease (COPD) and bronchiectasis, and in a range of settings such as randomised controlled therapy trials and population surveys.
Measured: Baseline to 24 months
EuroQoL Group 5-5 Dimension self-report questionnaire (EQ-5D-5L) to assess health state utilities
EQ-5D-5L consists of 2pg: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).
Five dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression.
Each dimension 5 levels: no problems, slight problems, moderate problems, severe problems, extreme problems.
Patient indicates their health state by ticking most appropriate statement in each of the five dimensions.
This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
EQ VAS records patient's self-rated health on a vertical visual analogue scale. Endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Measured: Baseline to 24 months
Healthcare utilisation costs and Quality Adjusted Life Years (QALYs) evaluation of the treatment intervention
Mean differences in healthcare utilisation costs and Quality Adjusted Life Years between both treatment groups will be estimated.
Costs will be ascertained from participants and study records. Health care utilisation will be on the basis of self-reported GP and hospital attendances and changes in concomitant medication. Health state utilities will be estimated via the EQ-5D-5L and will be used to weight survival up to 24 months to determine Quality Adjusted Life Years.
Measured: Baseline to 24 months
Health status assessed by COPD Assessment Test (CAT)
Measured: Baseline to 24 months
Clinic spirometry: post-bronchodilator FEV1 (Forced Expiratory Volume) (L)
Measured: Baseline to 24 months
Clinic spirometry: % predicted post-bronchodilator
Measured: Baseline to 24 months
Hospital admissions for all respiratory causes
Measured: Baseline to 24 months
Hospital admissions for all cardiac causes
All cardiac causes includes ischaemia, arrhythmia, heart failure, acute arrhythmia, non-ST-elevation myocardial infarction, urgent revascularisation (stent/angioplasty/coronary artery bypass grafting), and MACE events (includes myocardial infarction, sudden death, cardiac death or a fatal event in system organ classes for cardiac and vascular disorders, and serious and non-serious stroke).
Measured: Baseline to 24 months
Total Number of cardiac events: MACE plus acute arrhythmia, Non-ST-elevation myocardial infarction (NSTEMI), urgent revascularisation (stent/angioplasty/Coronary artery bypass grafting [CABGs]) and clinically diagnosed heart failure episodes.
Measured: Baseline to 24 months
Time to a composite outcome (includes any) of: all-case mortality; hospitalisation for COPD exacerbation, hospitalisation for primary cardiac cause (arrytmmia, ischaemia or heart failure) or MACE
Measured: Baseline to 24 months
COPD exacerbation rate (annualised)
Measured: Baseline to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2019
- Study start30 Jun 2020
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- The George Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Responsible party
- Sponsor
- Investigators
- Prof Christine Jenkins, Principal investigator, The George Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03917914
- Sponsor's protocol ID
- PACE in COPD
- Acronym
- PACE in COPD
- Status last verified
- May 2025
- First submitted
- 10 Apr 2019
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jenkins CR, Martin A, Chang CL, Beasley R, Wrobel JP, McDonald VM, Dobler CC, Yang IA, Farah CS, Cochrane B, Hillis GS, Polak Scowcroft C, Ranasinha CD, De Silva HA, Aggarwal AN, Billot L, Devaux A, Gianacas C, Galgey S, Hancox RJ; PACE investigators. Bisoprolol to prevent adverse cardiac events (PACE) in COPD: a multicentre, double-blind, randomised, controlled, phase 3 trial. Lancet Respir Med. 2026 Mar;14(3):203-214. doi: 10.1016/S2213-2600(25)00390-X. Epub 2026 Jan 21.
PubMed 41579873Martin A, Hancox RJ, Chang CL, Beasley R, Wrobel J, McDonald V, Dobler CC, Yang IA, Farah CS, Cochrane B, Hillis GS, Scowcroft CP, Aggarwal A, Di Tanna GL, Balicki G, Galgey S, Jenkins C. Preventing adverse cardiac events (PACE) in chronic obstructive pulmonary disease (COPD): study protocol for a double-blind, placebo controlled, randomised controlled trial of bisoprolol in COPD. BMJ Open. 2021 Aug 27;11(8):e053446. doi: 10.1136/bmjopen-2021-053446.
PubMed 34452971
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Adverse Cardiac Events in Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT03917914
- Acronym / sponsor ID
- PACE in COPD / PACE in COPD
- Keywords
- COPD, MACE
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- The George InstituteUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 17 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bisoprolol | Active comparator | Drug: Bisoprolol1.25, 2.5 or 5mg of bisoprolol daily |
| Placebo | Placebo comparator | Drug: Placebo Oral Tablet1.25, 2.5 or 5mg of matched placebo daily |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (17 listed)
- Concurrent therapy with any other β-blocker
- Resting HR <60bpm
- Unstable left HF (i.e. symptomatic and/or necessary change in management in the last 12 weeks, or in clinicians' opinion)
- Clinically significant pulmonary hypertension, which in the investigator's opinion would be a contraindication for β-blocker therapy
- Severe end-stage peripheral vascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BisoprololAs in arm description | Drug | Bisoprolol |
| Placebo Oral TabletAs in arm description | Drug | Placebo |
Primary outcome
All-cause mortality
Time frame: Baseline to 24 months
Composite outcome of the following that will be analysed using a win-ratio apprach according to clinical importance
Hospitalisation for COPD exacerbation
Time frame: Baseline to 24 months
Hospitalisation for primary cardiac cause (ischaemia, arrhythmia, heart failure or ischaemic stroke)
Time frame: Baseline to 24 months
Moderate COPD exacerbation - not hospitalised by treated with oral corticosteroids/antibiotics or both
Time frame: Baseline to 24 months
Cardiac Hospitalisation for cardiac cause other than ischemia, arrythmia or heart failure
Time frame: Baseline to 24 months
Respiratory hospitalisation for a respiratory cause other than COPD exacerbation
Time frame: Baseline to 24 months
Decrease in FEV1 or greatest FEV1% drop - largest decrease in FEV1 from post-bronchodiliator spirometry at baseline
Time frame: Baseline to 24 months
Mild COPD exacerbation - treated with increased inhalers/inhaler technique/addition of theophylline
Time frame: Baseline to 24 months
Higher SGRQ score (clinically important change >= 4)
Time frame: Baseline to 12 and 24 months
Higher CAT score (clinically important change >= 2)
Time frame: Baseline to 12 and 24 months
14 secondary outcomes
Time to first moderate-severe COPD Exacerbation
Time frame: Baseline to 24 months
Severe (hospital admission) COPD exacerbation rate (annualised)
Time frame: Baseline to 24 months
Number of events of composite (annualised) cardio-respiratory hospital admissions and MACE
Time frame: Baseline to 24 months
Quality of life assessed by St George's Respiratory Questionnaire (SGRQ)
Time frame: Baseline to 24 months
EuroQoL Group 5-5 Dimension self-report questionnaire (EQ-5D-5L) to assess health state utilities
Time frame: Baseline to 24 months
Healthcare utilisation costs and Quality Adjusted Life Years (QALYs) evaluation of the treatment intervention
Time frame: Baseline to 24 months
Health status assessed by COPD Assessment Test (CAT)
Time frame: Baseline to 24 months
Clinic spirometry: post-bronchodilator FEV1 (Forced Expiratory Volume) (L)
Time frame: Baseline to 24 months
Clinic spirometry: % predicted post-bronchodilator
Time frame: Baseline to 24 months
Hospital admissions for all respiratory causes
Time frame: Baseline to 24 months
Hospital admissions for all cardiac causes
Time frame: Baseline to 24 months
Total Number of cardiac events: MACE plus acute arrhythmia, Non-ST-elevation myocardial infarction (NSTEMI), urgent revascularisation (stent/angioplasty/Coronary artery bypass grafting [CABGs]) and clinically diagnosed heart failure episodes.
Time frame: Baseline to 24 months
Time to a composite outcome (includes any) of: all-case mortality; hospitalisation for COPD exacerbation, hospitalisation for primary cardiac cause (arrytmmia, ischaemia or heart failure) or MACE
Time frame: Baseline to 24 months
COPD exacerbation rate (annualised)
Time frame: Baseline to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Derived from this study: PubMed 41579873Jenkins CR, Martin A, Chang CL, Beasley R, Wrobel JP, McDonald VM, Dobler CC, Yang IA, Farah CS, Cochrane B, Hillis GS, Polak Scowcroft C, Ranasinha CD, De Silva HA, Aggarwal AN, Billot L, Devaux A, Gianacas C, Galgey S, Hancox RJ; PACE investigators. Bisoprolol to prevent adverse cardiac events (PACE) in COPD: a multicentre, double-blind, randomised, controlled, phase 3 trial. Lancet Respir Med. 2026 Mar;14(3):203-214. doi: 10.1016/S2213-2600(25)00390-X. Epub 2026 Jan 21.
- Derived from this study: PubMed 34452971Martin A, Hancox RJ, Chang CL, Beasley R, Wrobel J, McDonald V, Dobler CC, Yang IA, Farah CS, Cochrane B, Hillis GS, Scowcroft CP, Aggarwal A, Di Tanna GL, Balicki G, Galgey S, Jenkins C. Preventing adverse cardiac events (PACE) in chronic obstructive pulmonary disease (COPD): study protocol for a double-blind, placebo controlled, randomised controlled trial of bisoprolol in COPD. BMJ Open. 2021 Aug 27;11(8):e053446. doi: 10.1136/bmjopen-2021-053446.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof Christine Jenkins principal investigator
The George Institute
24 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bisoprolol in people with Chronic Obstructive Pulmonary Disease and Cardiovascular Diseases, run by The George Institute at 24 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Australia, New Zealand, India, Sri Lanka. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: Baseline to 24 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03917914, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025; AzTrials last refreshed its copy on 4 Nov 2026.