Study of the Sudden Heart Failure Participant Population in the US

NCT ID: NCT03566264

Last Updated: 2022-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-22

Study Completion Date

2020-12-15

Brief Summary

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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

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Conditions

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Heart Decompensation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Participants hospitalized with ADHF

Non-Interventional

Intervention Type OTHER

Non-Interventional

Interventions

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Non-Interventional

Non-Interventional

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Bristol-Myers Squibb

Princeton, New Jersey, United States

Site Status

Local Institution

Princeton, New Jersey, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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CV013-031

Identifier Type: -

Identifier Source: org_study_id

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