Study Stopped
Program has been terminated.
Study of the Sudden Heart Failure Participant Population in the US
Characterizing the Acute Decompensated Heart Failure (ADHF) Patient Population in the United States (US)
1 other identifier
observational
N/A
1 country
2
Brief Summary
An observational study using data from a large US electronic health record database to find participants hospitalized with ADHF who do not have a concurring heart attack
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Aug 2017
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 22, 2017
CompletedFirst Submitted
Initial submission to the registry
April 24, 2018
CompletedFirst Posted
Study publicly available on registry
June 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2020
CompletedJuly 8, 2022
July 1, 2022
3.3 years
April 24, 2018
July 6, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
Incidence of comorbid events among hospitalized ADHF participants
In the 30 days after discharge
Incidence of participants hospitalized with ADHF
Up to 66 months
Incidence of participants hospitalized with ADHF
In the 30 days after discharge
Incidence of comorbid events among hospitalized ADHF participants
Up to 66 months
Study Arms (1)
Participants hospitalized with ADHF
Interventions
Eligibility Criteria
Study population will be participants hospitalized with ADHF who do not have a coincident myocardial infarction and who have at least 6 months of activity in the database prior to the hospitalization
You may qualify if:
- Age 18 years or older on the index date
- At least 6 months of activity in the database
- An inpatient visit with at least one of the following ICD-9 or ICD-10 diagnosis codes (ICD-9 diagnosis codes: 428.xx, 785.51 or ICD-10 diagnosis codes: I50.xx, R57.0) in the primary or secondary position OR mention of "heart failure" on the admission record
You may not qualify if:
- An average LVEF ≥ 40 during the hospitalization
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Bristol-Myers Squibb
Princeton, New Jersey, 08540, United States
Local Institution
Princeton, New Jersey, 08540, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2018
First Posted
June 25, 2018
Study Start
August 22, 2017
Primary Completion
December 15, 2020
Study Completion
December 15, 2020
Last Updated
July 8, 2022
Record last verified: 2022-07