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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03515655
Recruitment Status : Active, not recruiting
First Posted : May 3, 2018
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease
Heart Failure

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Study Type : Observational
Estimated Enrollment : 99209 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Characterizing Acute Heart Failure With Reduced Ejection Fraction Hospitalization Outcomes
Actual Study Start Date : February 21, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure




Primary Outcome Measures :
  1. Incidence of 30 day mortality [ Time Frame: 30 days ]
  2. Incidence of 30 day readmission [ Time Frame: 30 days ]
  3. Incidence of a prolonged length of stay [ Time Frame: 30 days ]
  4. Incidence of participants hospitalized with AHF with reduced ejection fraction [ Time Frame: 6 years ]

Secondary Outcome Measures :
  1. Distribution of socio-demographic characteristics in participants hospitalized for acute HFrEF [ Time Frame: 6 years ]
    Socio-demographic characteristics will be summarized using descriptive statistics

  2. Distribution of clinical characteristics in participants hospitalized for acute HFrEF [ Time Frame: 6 years ]
    Clinical characteristics will be summarized using descriptive statistics



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515655


Locations
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United States, New Jersey
Local Institution
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03515655     History of Changes
Other Study ID Numbers: CV013-029
First Posted: May 3, 2018    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases