Study of the Sudden Heart Failure Participant Population... | NCT03566264

Studies
Study of the Sudden Heart Failure Participant Population in the US

NCT03566264

Sponsor

Bristol-Myers Squibb

Status

Withdrawn

Last Update Posted

Jul 8, 2022Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Heart Decompensation

Interventions

Non-Interventional

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Program has been terminated.

Expanded Access Info

Start Date

Aug 22, 2017Actual

Primary Completion Date

Dec 15, 2020Actual

Completion Date

Dec 15, 2020Actual

First Submitted Date

Apr 24, 2018

First Submission Date that Met QC Criteria

Jun 20, 2018

First Posted Date

Jun 25, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2022

Last Update Posted Date

Jul 8, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Participants hospitalized with ADHF			Other: Non-Interventional

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non-Interventional	Other	Non-Interventional	Participants hospitalized with ADHF

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bristol-Myers Squibb		Princeton	New Jersey	08540	United States
Local Institution

References Module

Citations

Not provided

Label	URL
BMS Clinical Trial Information	View source
Investigator Inquiry Form	View source
FDA Safety Alerts and Recalls

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases