A Study of Patients Hospitalized With Acute Heart Failure With Reduced Ejection Fraction (HFrEF)

June 19, 2018 updated by: Bristol-Myers Squibb

Characterizing Acute Heart Failure With Reduced Ejection Fraction Hospitalization Outcomes

A study of participants hospitalized with acute heart failure with reduced ejection fraction

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

99209

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Princeton, New Jersey, United States, 08540
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population will be patients who were hospitalized with acute heart failure with an average reduced ejection fraction≤40during hospitalization, and who do not have a coincident myocardial infarction and who have at least 6 months of activity in the database prior to the hospitalization.

Description

Inclusion Criteria:

  • An average left ventricular ejection fraction (LVEF) < 40% over the entire index hospitalization
  • Age 18 years or older on the index date
  • At least 6 months of activity in the databaseprior to the index date

Exclusion Criteria:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of 30 day mortality
Time Frame: 30 days
30 days
Incidence of 30 day readmission
Time Frame: 30 days
30 days
Incidence of a prolonged length of stay
Time Frame: 30 days
30 days
Incidence of participants hospitalized with AHF with reduced ejection fraction
Time Frame: 6 years
6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distribution of socio-demographic characteristics in participants hospitalized for acute HFrEF
Time Frame: 6 years
Socio-demographic characteristics will be summarized using descriptive statistics
6 years
Distribution of clinical characteristics in participants hospitalized for acute HFrEF
Time Frame: 6 years
Clinical characteristics will be summarized using descriptive statistics
6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2018

Primary Completion (Anticipated)

December 31, 2018

Study Completion (Anticipated)

December 31, 2018

Study Registration Dates

First Submitted

April 23, 2018

First Submitted That Met QC Criteria

April 23, 2018

First Posted (Actual)

May 3, 2018

Study Record Updates

Last Update Posted (Actual)

June 20, 2018

Last Update Submitted That Met QC Criteria

June 19, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV013-029

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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