Study of the Sudden Heart Failure Participant Population in the US

Heart Decompensation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03566264
• Other study ID #: CV013-031
• Status: Withdrawn
• Start date: August 22, 2017
• Est. completion date: December 15, 2020

Study information

• Verified date: July 2022
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 15, 2020
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Decompensation
• Heart Failure

Intervention

Other:
• Non-Interventional
Non-Interventional

Locations

Country	Name	City	State
United States	Bristol-Myers Squibb	Princeton	New Jersey
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 comorbid events among hospitalized ADHF participants		In the 30 days after discharge
Primary	Incidence of participants hospitalized with ADHF		Up to 66 months
Primary	Incidence of participants hospitalized with ADHF		In the 30 days after discharge
Primary	Incidence of comorbid events among hospitalized ADHF participants		Up to 66 months

External Links

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