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

Heart Failure Clinical Trial

Official title:

Characterizing Acute Heart Failure With Reduced Ejection Fraction Hospitalization Outcomes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03515655
• Other study ID #: CV013-029
• Status: Active, not recruiting
• Start date: February 21, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: June 2018
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 99209
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
United States	Local Institution	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of 30 day mortality		30 days
Primary	Incidence of 30 day readmission		30 days
Primary	Incidence of a prolonged length of stay		30 days
Primary	Incidence of participants hospitalized with AHF with reduced ejection fraction		6 years
Secondary	Distribution of socio-demographic characteristics in participants hospitalized for acute HFrEF	Socio-demographic characteristics will be summarized using descriptive statistics	6 years
Secondary	Distribution of clinical characteristics in participants hospitalized for acute HFrEF	Clinical characteristics will be summarized using descriptive statistics	6 years

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form