Heart FailureNCT00583089
Decompensation Detection Study
An observational study of Heart Failure, run by Boston Scientific Corporation.
Trial summary
To gather data and analyze decompensation events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 699 participants
- Where
- No sites listed yet
- Study dates
- Mar 2006to Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Heart failure patients
Who may be able to join
- Patients implanted with an approved Guidant CRT-D HF device programmed to CRT therapy in VDD or DDD mode.
- Patients prescribed to the LATITUDE(R) system configured for at least weekly device interrogations and symptoms reporting.
- Patients willing to use the LATITUDE(R) enabled weight scale.
Who cannot join
- Patients that require adaptive rate pacing (rate-responsive modes).
- Patients that have received routinely scheduled intravenous inotropic therapy as part of their drug regimen within the past 90 days.
- Both
About this study
To gather data and analyze decompensation events.
- Conditions
- Heart Failure
- Medical subject headings
- Heart Failure
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 | Algorithm Test Set | |
| 2 | Algorithm Development Set |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data collection and analysis.
Measured: End of patient follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2007 (estimated)
- Study startMar 2006
- Primary completionMar 2008
- Study completionMar 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 Boston Scientific CorporationThe 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
- Prospective
- Enrolment
- 699 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregory Ewald, M.D., Principal investigator, Washington University School of MedicineF. Roosevelt Gilliam, M.D., Principal investigator, Cardiology Associates of Northeast Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00583089
- Sponsor's protocol ID
- DECODE
- Status last verified
- Feb 2017
- First submitted
- 20 Dec 2007
- Last updated
- 6 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decompensation Detection Study
- ClinicalTrials.gov ID
- NCT00583089
- Acronym / sponsor ID
- DECODE
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 699 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 31 Dec 2007 (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.
To gather data and analyze decompensation events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Algorithm Test Set |
| 2 | – | –Algorithm Development Set |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Heart failure patients
Key inclusion criteria (3 listed)
- Patients implanted with an approved Guidant CRT-D HF device programmed to CRT therapy in VDD or DDD mode.
- Patients prescribed to the LATITUDE(R) system configured for at least weekly device interrogations and symptoms reporting.
- Patients willing to use the LATITUDE(R) enabled weight scale.
Key exclusion criteria (3 listed)
- Patients that require adaptive rate pacing (rate-responsive modes).
- Patients that have received routinely scheduled intravenous inotropic therapy as part of their drug regimen within the past 90 days.
- Both
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
Data collection and analysis.
Time frame: End of patient follow up.
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 6 Feb 2017.
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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.
Gregory Ewald, M.D. principal investigator
Washington University School of Medicine
F. Roosevelt Gilliam, M.D. principal investigator
Cardiology Associates of Northeast Arkansas
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Boston Scientific Corporation.
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 3 inclusion and 3 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 6 Feb 2017. 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?
Data collection and analysis. (time frame: End of patient follow up.). 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 6 Feb 2017.