Study of the Sudden Heart Failure Participant Population in the US

Withdrawn

• Conditions: Heart Decompensation

• 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

Study Timeline

• Study Start: 2017-08-22
• Study First Submitted: 2018-04-24
• Study First Submitted QC: 2018-06-20
• Study First Posted: 2018-06-25
• Primary Completion: 2020-12-15
• Study Completion: 2020-12-15
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-06
• Last Update Posted: 2022-07-08

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• Status: WITHDRAWN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

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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

Trial Locations

Locations (2)

Bristol-Myers Squibb; 🇺🇸 Princeton, New Jersey, United States

Local Institution; 🇺🇸 Princeton, New Jersey, United States