Heart FailureEconoHeartNCT01084564
Economic Evaluation of Heart Failure Management in Colombian Clinics
An observational study of Heart Failure and Asthma, run by AstraZeneca.
Trial summary
Cost effectiveness analysis of local management of patients diagnosed with heart failure disease compared with an ideal guideline-based management. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Heart Failure, Asthma
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Jun 2008
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Moderate to severe uncontrolled asthma.
Who may be able to join
- Asthma moderate to severe.
Who cannot join
None listed.
About this study
Cost effectiveness analysis of local management of patients diagnosed with heart failure disease compared with an ideal guideline-based management.
- Conditions
- Heart Failure, Asthma
- Keywords
- Cost-effectiveness analysis, Colombia
- Medical subject headings
- Heart Failure, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | moderate to severe uncontrolled asthma |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine cost-effectiveness of Heart Failure management in 3 Heart-specialized clinics in Bogotá Colombia
Measured: 12 months
Incremental cost-effectiveness ratio from using Symbicort as symbicort as Maintenance and Reliever Therapy (SMART) when compared with its competitive alternatives
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2010 (estimated)
- Study startJan 2008
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Rodolfo Dennis, M.D., Study director, Pontificia Universidad JaverianaMARÍA XIMENA ROJAS, M.D., Principal investigator, Pontificia Universidad Javeriana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01084564
- Sponsor's protocol ID
- NIS-CCO-ATA-2007/1
- Acronym
- EconoHeart
- Status last verified
- Mar 2010
- First submitted
- 9 Mar 2010
- Last updated
- 10 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Economic Evaluation of Heart Failure Management in Colombian Clinics
- ClinicalTrials.gov ID
- NCT01084564
- Acronym / sponsor ID
- EconoHeart / NIS-CCO-ATA-2007/1
- Conditions
- Heart Failure, Asthma
- Keywords
- Cost-effectiveness analysis, Colombia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 10 Mar 2010 (estimated)
- 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.
Cost effectiveness analysis of local management of patients diagnosed with heart failure disease compared with an ideal guideline-based management.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –moderate to severe uncontrolled asthma |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Moderate to severe uncontrolled asthma.
Key inclusion criteria (1 listed)
- Asthma moderate to severe.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine cost-effectiveness of Heart Failure management in 3 Heart-specialized clinics in Bogotá Colombia
Time frame: 12 months
Incremental cost-effectiveness ratio from using Symbicort as symbicort as Maintenance and Reliever Therapy (SMART) when compared with its competitive alternatives
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 10 Mar 2010.
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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.
Rodolfo Dennis, M.D. study director
Pontificia Universidad Javeriana
MARÍA XIMENA ROJAS, M.D. principal investigator
Pontificia Universidad Javeriana
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Asthma, run by AstraZeneca.
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 1 inclusion and 0 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 10 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
To determine cost-effectiveness of Heart Failure management in 3 Heart-specialized clinics in Bogotá Colombia (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2010.