CClinicalTrials.gg
Status unknownNCT03515655Updated Jun 20, 2018

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

An observational study in Heart Failure, sponsored by Bristol-Myers Squibb. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-20.

Sponsored by Bristol-Myers Squibb · Observational

The sponsor has not verified this record recently (last verified Jun 2018), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
99,209
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Heart Failure

Browse trials for

03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's planned enrollment of 99,209 is above the median of 200 across 1,679 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

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

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

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
99,209 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  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 outcomes

  1. Distribution of socio-demographic characteristics in participants hospitalized for acute HFrEF

    Socio-demographic characteristics will be summarized using descriptive statistics

    Time frame: 6 years

  2. Distribution of clinical characteristics in participants hospitalized for acute HFrEF

    Clinical characteristics will be summarized using descriptive statistics

    Time frame: 6 years

07

Study locations

1 site
  • Local Institution
    Princeton, New Jersey 08540, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 20, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03515655
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
May 3, 2018
Start date
Feb 21, 2018
Primary completion
Dec 31, 2018 (estimated)
Completion
Dec 31, 2018 (estimated)
Last update
Jun 20, 2018

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion