Status: Finalised
First registered on:
30/03/2016
Last updated on:
19/12/2018
1. Study identification
EU PAS Register NumberEUPAS12987
Official titleEvaluation of the undertreatment and disease outcomes for patients with coexisting Heart Failure and Chronic Obstructive Pulmonary Disease
Study title acronym
Study typeObservational study
Brief description of the studyThe objectives of this study are to assess the prevalence of comorbid diagnosed COPD and HF and to describe therapies prescribed and diagnostic tests undertaken by clinicians in real-life clinical practice for patients with COPD and/or HF. Additionally, it will evaluate the long-term respiratory and cardiovascular outcomes associated with the prescribed therapies for patients with comorbid COPD and HF. This study will be conducted using historical data from patients with COPD and/or heart failure. The prevalence of comorbid diagnosed COPD and HF will be assessed at the time of most recent data available for each patient, from all patients with a diagnosis of either COPD and/or HF. COPD and HF therapies prescribed and diagnostic tests undertaken will be considered in the year prior to most recent data available, between January 2010 to date for patients, comparing patients with comorbid COPD and HF to those with COPD alone and to those with HF alone. Cardiovascular and respiratory outcomes will be assessed for patients with comorbid COPD and HF, comparing those with adequate versus inadequate treatment for COPD/HF (according to guidelines). These outcomes will be assessed over at least one year and up to three years.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Department/Research groupResearch in Real Life Ltd
Organisation/affiliationOPRI Pte Ltd
Details of (Primary) lead investigator
Title Miss
Last name Martin
First name Jessica
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)
Countries in which this study is being conducted
National study
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed20/11/2015
Start date of data collection05/02/2016
Start date of data analysis
Date of interim report, if expected
Date of final study report13/03/201708/12/2017
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesNovartis100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Price
First name David
Address line 160 Paya Lebar Road
Address line 2Paya Lebar Square
Address line 3Level 5, Unit 33 & 34
CitySingapore
Postcode409051
CountrySingapore
Phone number (incl. country code)6568097251
Alternative phone number
Fax number (incl. country code)
Public Enquiries
Title Professor
Last name Price
First name David
Address line 160 Paya Lebar Road
Address line 2Paya Lebar Square
Address line 3Level 5, Unit 33 & 34
CitySingapore
Postcode409051
CountrySingapore
Phone number (incl. country code)6568097251
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Not applicable (disease/epidemiology study)
7. Medical conditions to be studied
Medical condition(s)Yes
Chronic obstructive pulmonary disease
Cardiac failure
8. Population under study
Age
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects129164
Additional information
Clinical Practice Research Datalink estimate: 55,338 patients with a diagnosis of COPD, 18,374 patients with diagnosis of HF and 1996 patients with diagnosis of both COPD and HF.
Optimum Patient Care Research Database estimate: 39,630 patients with diagnosis of COPD, 10,003 patients with diagnosis of HF and 3823 patients with diagnosis of both COPD and HF.
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources registered with ENCePP
Sources of data
Routine primary care electronic patient registry
11. Scope of the study
What is the scope of the study?
Disease epidemiology
Primary scope : Disease epidemiology
12. Main objective(s)
What is the main objective of the study?
To assess the prevalence of comorbid diagnosed COPD and HF
To describe therapies prescribed and diagnostic tests undertaken by clinicians in real-life clinical practice for patients with COPD and/or HF
To evaluate the long-term respiratory and cardiovascular outcomes associated with the prescribed therapies for patients with comorbid COPD and HF
Are there primary outcomes?No
Are there secondary outcomes?No
13. Study design
What is the design of the study?
Cohort study
14. Follow-up of patients
Will patients be followed up?Not applicable/no follow-up
15. Data analysis plan
Please provide a brief summary of the analysis method
The proportion of patients with a coexisting diagnosis of COPD and HF of all patients with a diagnosis of COPD and separately of all patients with a diagnosis of HF will be calculated.
Diagnostic tests and prescription patterns will be reported as count and percentage and compared using conditional logistic regression within each severity group.
Prescribing patterns will be presented graphically as a percentage of patients prescribed each treatment over the one year period for HF and COPD treatments separately.
Rates of MACE, COPD exacerbations, HF hospitalizations and cardiovascular events after 1 year of follow-up will be compared using conditional Poisson regression.
Deaths after 1 year of follow-up will be compared using conditional logistic regression.
Cox regression models will be used to analyze time to first MACE, COPD exacerbation, HF hospitalization, cardiovascular event and death.
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
Not submitted
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
None
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
