Study of the Sudden Heart Failure Participant Population in the US

July 6, 2022 updated by: Bristol-Myers Squibb

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

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
      • Princeton, New Jersey, United States, 08540
        • Bristol-Myers Squibb

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

Study population will be participants hospitalized with ADHF 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:

  • 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 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants hospitalized with ADHF
Other: Non-Interventional
Non-Interventional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of comorbid events among hospitalized ADHF participants
Time Frame: In the 30 days after discharge
In the 30 days after discharge
Incidence of participants hospitalized with ADHF
Time Frame: Up to 66 months
Up to 66 months
Incidence of participants hospitalized with ADHF
Time Frame: In the 30 days after discharge
In the 30 days after discharge
Incidence of comorbid events among hospitalized ADHF participants
Time Frame: Up to 66 months
Up to 66 months

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)

August 22, 2017

Primary Completion (Actual)

December 15, 2020

Study Completion (Actual)

December 15, 2020

Study Registration Dates

First Submitted

April 24, 2018

First Submitted That Met QC Criteria

June 20, 2018

First Posted (Actual)

June 25, 2018

Study Record Updates

Last Update Posted (Actual)

July 8, 2022

Last Update Submitted That Met QC Criteria

July 6, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV013-031

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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