Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000548831
Ethics application status
Approved
Date submitted
22/05/2012
Date registered
23/05/2012
Date last updated
18/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Waikato Follow-up Study of People Admitted to Hospital with Chronic Obstructive Pulmonary Disease
Scientific title
In patients with exacerbation of chronic obstructive pulmonary disease (COPD) who have abnormal cardiac biomarkers, compared to those who do not have abnormal cardiac biomarkers and those who do not receive ventilatory support, do the abnormalities of cardiac biomarkers normalise when the patients are in stable COPD, do they reflect underlying abnormal cardiac function and do they have higher morbidity and mortality rate?
Secondary ID [1] 280536 0
Nil
Universal Trial Number (UTN)
U1111-1131-0994
Trial acronym
BREATHE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic obstructive pulmonary disease 286532 0
heart failure 286533 0
Condition category
Condition code
Respiratory 286799 286799 0 0
Chronic obstructive pulmonary disease
Cardiovascular 286800 286800 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
In patients with exacerbation of COPD, the levels of cardiac biomarkers will be measured during hospitalisation, before and after non-invasive ventilation (in those who receive non-invasive ventilation) and during 30-day follow up. Those with abnormal cardiac biomarkers will have cardiac functional assessment to see if they have any correlation. They will also be followed up for a year for morbidity and mortality. We also compared levels of cardiac biomarkers in patients who received nebulised bronchodilators, frusemide, oxygen supplementation, who had acidaemia, hypercapnia and hypoxaemia and according to severity score, to determine factors for abnormal cardiac biomarkers during exacerbations of COPD.
Intervention code [1] 284913 0
Not applicable
Comparator / control treatment
In patients receiving non-invasive ventilation for hypercapnic respiratory failure, the trend of cardiac biomarkers will be compared to those patients who non-invasive ventilation is not indicated.
Control group
Active

Outcomes
Primary outcome [1] 287170 0
cardiac biomarkers (N-terminal pro-brain natriuretic peptide, NT-proBNP and troponin T) levels
Timepoint [1] 287170 0
at presentation, 12 hours, 72 hours (or on day of discharge from hospital whichever is earlier) and at 30 days following hospitalisation (stable).
Primary outcome [2] 287171 0
cardiac functional indices from cardiac imaging - cardiac magnetic resonance imaging (CMR) - in patients with elevated cardiac biomarkers i.e. NT-proBNP
Timepoint [2] 287171 0
during hospitalisation (exacerbation) and 30-day follow up (stable)
Secondary outcome [1] 297549 0
all cause mortality
Timepoint [1] 297549 0
during hospitalisation, at 30 days and at 1 year follow-up
Secondary outcome [2] 297550 0
further exacerbations and hospitalisations from patient interview and data linkage to patient medical records
Timepoint [2] 297550 0
at 30 days and at 1 year follow-up
Secondary outcome [3] 297551 0
cardiac events from patient interview and data linkage to patient medical records
Timepoint [3] 297551 0
at 30 days and at 1 year follow-up
Secondary outcome [4] 297552 0
beta-agonists blood level
Timepoint [4] 297552 0
at presentation
Secondary outcome [5] 297553 0
inflammatory markers blood levels
Timepoint [5] 297553 0
at presentation and at 30 days follow up

Eligibility
Key inclusion criteria
Physician diagnosis of COPD.
Fixed airflow obstruction (FEV1/FVC <70% and FEV1<80% of predicted) at presentation, in the last 6 months or at 30-day follow up.
Over 40 years of age.
At least 10pack years smoking history.
Acute exacerbation of COPD as defined by dyspnoea, cough or sputum purulence severe enough to warrant hospital admission, respiratory failure or change in mental status due to COPD.
In the patients receiving non-invasive ventilation, arterial blood gas indices of hypercapnic respiratory failure.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Respiratory physician diagnosis of interstitial lung disease or bronchiectasis.
Radiological diagnosis of pneumonia.
Known diagnosis of clinically significant valvular heart disease.
Known diagnosis of other terminal illness with prognosis less than 2 years.
Inability to perform spirometry.
Patient refusal to participate in the study or unable to give informed consent.
Likely to leave Waikato region or become uncontactable during follow-up period.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/06/2012
Actual
6/08/2012
Date of last participant enrolment
Anticipated
Actual
25/07/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
176
Recruitment outside Australia
Country [1] 4329 0
New Zealand
State/province [1] 4329 0
Waikato

Funding & Sponsors
Funding source category [1] 285300 0
Hospital
Name [1] 285300 0
Respiratory Department Research Funding, Waikato Hospital
Country [1] 285300 0
New Zealand
Primary sponsor type
Hospital
Name
Department of Respiratory Medicine, Waikato Hospital
Address
Department of Respiratory Medicine, Waikato Hospital, Pembroke Street, Private Bag 3200, Hamilton 3240
Country
New Zealand
Secondary sponsor category [1] 284161 0
None
Name [1] 284161 0
Address [1] 284161 0
Country [1] 284161 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287310 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 287310 0
Ethics committee country [1] 287310 0
New Zealand
Date submitted for ethics approval [1] 287310 0
29/05/2012
Approval date [1] 287310 0
25/06/2012
Ethics approval number [1] 287310 0
LRS/12/06/019/AM02

Summary
Brief summary
COPD is very common and carries significant health and socioeconomic burden. Blood markers of impaired heart function are found to be raised in some patients with chronic obstructive pulmonary disease (COPD). This study is looking at the abnormality in the blood levels of these markers in COPD exacerbations and during stable period, to see if they are related to impaired heart function and the factors that might contribute to the abnormality. Heart function will be assessed by MRI scan of the heart. Those having acute severe worsening of their disease will require assisted breathing with a mask attached to a ventilator, named non-invasive ventilator (NIV), which is also in heart failure to reduce the work load of the heart. This study is also trying to find out if the level of these blood markers changes after NIV. This would suggest that there is an underlying impairment in heart function in patients with COPD which is not normally looked for. The outcome of this study will improve the treatment of COPD.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34214 0
Dr Eskandarain Shafuddin
Address 34214 0
Waikato Hospital
Pembroke Street
Private Bag 3200
Hamilton 3240
New Zealand
Country 34214 0
New Zealand
Phone 34214 0
+6478398899
Fax 34214 0
Email 34214 0
eskandarain.shafuddin@waikatodhb.health.nz
Contact person for public queries
Name 17461 0
Dr Dr Eskandarain Shafuddin
Address 17461 0
Department of Respiratory Medicine,
Waikato Hospital,
Pembroke Street, Private Bag 3200,
Hamilton 3240
Country 17461 0
New Zealand
Phone 17461 0
+64(0)78398899
Fax 17461 0
Email 17461 0
eskandarain.shafuddin@waikatodhb.health.nz
Contact person for scientific queries
Name 8389 0
Dr Dr Eskandarain Shafuddin
Address 8389 0
Department of Respiratory Medicine,
Waikato Hospital,
Pembroke Street, Private Bag 3200,
Hamilton 3240
Country 8389 0
New Zealand
Phone 8389 0
+64(0)78398899
Fax 8389 0
Email 8389 0
eskandarain.shafuddin@waikatodhb.health.nz

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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