Study of the Sudden Heart Failure Participant Population in the US
Withdrawn
- Conditions
- Heart Decompensation
- Interventions
- Other: Non-Interventional
- Registration Number
- NCT03566264
- Lead Sponsor
- Bristol-Myers Squibb
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- 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
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Exclusion Criteria
- 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
Other protocol defined inclusion/exclusion criteria could apply
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants hospitalized with ADHF Non-Interventional -
- Primary Outcome Measures
Name Time Method Incidence of participants hospitalized with ADHF In the 30 days after discharge Incidence of comorbid events among hospitalized ADHF participants Up to 66 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Bristol-Myers Squibb
🇺🇸Princeton, New Jersey, United States
Local Institution
🇺🇸Princeton, New Jersey, United States