Status: Finalised
First registered on:
26/10/2015
Last updated on:
19/12/2018
1. Study identification
EU PAS Register NumberEUPAS11387
Official titleUnderuse of beta-blockers in patients with heart failure and COPD
Study title acronym
Study typeObservational study
Brief description of the studyCardiovascular comorbidity is common in chronic obstructive pulmonary disease (COPD). Retrospective cohort studies have shown putative benefits of beta-blockers in COPD. Although beta-blockers are established therapy in heart failure (HF) guidelines, including for patients with COPD, there remain concerns regarding bronchoconstriction even with cardioselective beta-blockers. We aim to assess the real life use of beta-blockers for patients with HF who also have COPD.
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 signed15/06/2015
Start date of data collection26/06/2015
Start date of data analysis
Date of interim report, if expected
Date of final study report20/11/201523/11/2016
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherRiRL100
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Price
First name David
Address line 12 Changi Business Park Avenue 1
Address line 2Level 2
Address line 3486015
CitySingapore
Postcode
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 12 Changi Business Park Avenue 1
Address line 2Level 2
Address line 3486015
CitySingapore
Postcode
CountrySingapore
Phone number (incl. country code)6568097251
Alternative phone number
Fax number (incl. country code)
6. Study drug(s) information
Substance class (ATC Code)C07 (BETA BLOCKING AGENTS)
Substance class (ATC Code)C09 (AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM)
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 subjects125000
Additional information
90,000 COPD
25,000 HF
10,000 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?
Drug utilisation study
Primary scope : Drug utilisation study
12. Main objective(s)
What is the main objective of the study?
To assess the real life use of beta-blockers for patients with HF who also have COPD
Are there primary outcomes?No
Are there secondary outcomes?No
13. Study design
What is the design of the study?
Cross-sectional 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
Treatments for HF will be compared between groups using multinomial logistic regression, and the odds ratios, 95% confidence intervals, and p-values will be reported.
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
