Heart FailureNCT03515655
A Study of Patients Hospitalized With Acute Heart Failure With Reduced Ejection Fraction (HFrEF)
An observational study of Heart Failure, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
A study of participants hospitalized with acute heart failure with reduced ejection fraction Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 99,209 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2018to 31 Dec 2018
- 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: The study population will be patients who were hospitalized with acute heart failure with an average reduced ejection fraction≤40during hospitalization, and who do not have a coincident myocardial infarction and who have at least 6 months of activity in the database prior to the hospitalization.
Who may be able to join
- An average left ventricular ejection fraction (LVEF) < 40% over the entire index hospitalization
- Age 18 years or older on the index date
- At least 6 months of activity in the databaseprior to the index date
Who cannot join
- Any code for myocardial infarction (ICD-9 diagnosis code: 410.xx, ICD-10 diagnosis code: I21.xx) or related terms such as "myocardial infarction", "mi", "infarct" or "heart attack" occurring during the index hospitalization
- Other protocol defined inclusion/exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterizing Acute Heart Failure With Reduced Ejection Fraction Hospitalization Outcomes
A study of participants hospitalized with acute heart failure with reduced ejection fraction
- Conditions
- Heart Failure
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of 30 day mortality
Measured: 30 days
Incidence of 30 day readmission
Measured: 30 days
Incidence of a prolonged length of stay
Measured: 30 days
Incidence of participants hospitalized with AHF with reduced ejection fraction
Measured: 6 years
Secondary outcomes (2)
Distribution of socio-demographic characteristics in participants hospitalized for acute HFrEF
Socio-demographic characteristics will be summarized using descriptive statistics
Measured: 6 years
Distribution of clinical characteristics in participants hospitalized for acute HFrEF
Clinical characteristics will be summarized using descriptive statistics
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2018
- Study start21 Feb 2018
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
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 Bristol-Myers SquibbThe 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
- 99,209 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03515655
- Sponsor's protocol ID
- CV013-029
- Status last verified
- Jun 2018
- First submitted
- 23 Apr 2018
- Last updated
- 20 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Acute Heart Failure With Reduced Ejection Fraction Hospitalization Outcomes
- ClinicalTrials.gov ID
- NCT03515655
- Acronym / sponsor ID
- CV013-029
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 99,209 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 21 Feb 2018 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 3 May 2018 (actual)
- 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.
A study of participants hospitalized with acute heart failure with reduced ejection fraction
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be patients who were hospitalized with acute heart failure with an average reduced ejection fraction≤40during hospitalization, and who do not have a coincident myocardial infarction and who have at least 6 months of activity in the database prior to the hospitalization.
Key inclusion criteria (3 listed)
- An average left ventricular ejection fraction (LVEF) < 40% over the entire index hospitalization
- Age 18 years or older on the index date
- At least 6 months of activity in the databaseprior to the index date
Key exclusion criteria (2 listed)
- Any code for myocardial infarction (ICD-9 diagnosis code: 410.xx, ICD-10 diagnosis code: I21.xx) or related terms such as "myocardial infarction", "mi", "infarct" or "heart attack" occurring during the index hospitalization
- Other protocol defined inclusion/exclusion criteria could apply
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
Incidence of 30 day mortality
Time frame: 30 days
Incidence of 30 day readmission
Time frame: 30 days
Incidence of a prolonged length of stay
Time frame: 30 days
Incidence of participants hospitalized with AHF with reduced ejection fraction
Time frame: 6 years
2 secondary outcomes
Distribution of socio-demographic characteristics in participants hospitalized for acute HFrEF
Time frame: 6 years
Distribution of clinical characteristics in participants hospitalized for acute HFrEF
Time frame: 6 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
- BMS Clinical Trial InformationLink provided by the sponsor.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Bristol-Myers Squibb at 1 site in United States.
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 2 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: status not confirmed, as of the sponsor's last update on 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Incidence of 30 day mortality (time frame: 30 days). The study lists 4 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 20 Jun 2018.