Characterizing the Acute Decompensated Heart Failure (ADHF) Patient Population in the United States (US)

Bristol-Myers Squibb2 sites in 1 countryAugust 22, 2017

ConditionsHeart Decompensation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Heart Decompensation
Sponsor: Bristol-Myers Squibb
Locations: 2
Primary Endpoint: Incidence of participants hospitalized with ADHF
Status: Withdrawn
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

August 22, 2017

End Date

December 15, 2020

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

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

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