NCT03515655

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
99,209

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 21, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 3, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

June 20, 2018

Status Verified

June 1, 2018

Enrollment Period

10 months

First QC Date

April 23, 2018

Last Update Submit

June 19, 2018

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (4)

  • Incidence of 30 day mortality

    30 days

  • Incidence of 30 day readmission

    30 days

  • Incidence of a prolonged length of stay

    30 days

  • Incidence of participants hospitalized with AHF with reduced ejection fraction

    6 years

Secondary Outcomes (2)

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

    6 years

  • Distribution of clinical characteristics in participants hospitalized for acute HFrEF

    6 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Princeton, New Jersey, 08540, United States

Location

Related Links

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2018

First Posted

May 3, 2018

Study Start

February 21, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

June 20, 2018

Record last verified: 2018-06

Locations

US(1)