Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00508638
Status:
COMPLETED
Last Update Posted:
2017-04-19
First Post:
2007-07-26
Brief Title:
Identifying High- and Low-Risk Heart Failure Patients in the Emergency Department The Stratify Study
Sponsor:
Vanderbilt University
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
Improving Heart Failure Risk Stratification in the ED
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Stratify
Brief Summary:
People with heart failure HF symptoms who are seen in the emergency department ED are often admitted to the hospital even though it may not be necessary This study will gather information from HF patients seen in the ED to develop a decision-making tool that will help doctors predict the risk of HF-related death or serious complications Improving the ability of ED doctors to effectively and safely manage low-risk HF patients should lead to fewer unnecessary hospitalizations
Detailed Description:
HF is a life-threatening condition in which the heart can no longer pump enough blood to the rest of the body Symptoms of HF can include shortness of breath nausea fatigue swelling of the feet or abdomen and an irregular or rapid pulse A critical challenge facing ED doctors is how to best manage people who come into the ED with symptoms of HF Currently most people evaluated for HF in the ED are admitted to the hospital however not all of these people are in need of such intensive treatment It is estimated that up to 50 of HF-related hospital admissions could be avoided Improving the ability of the ED doctor to effectively and safely manage low-risk HF patients is essential to avoid unnecessary hospitalizations This study will gather information from ED patients at risk for HF to develop an algorithm decision tool that will predict patients risk for inpatient or outpatient death and serious complications from HF This decision tool will be distributed worldwide for ED use and will hopefully reduce the costs of HF care by appropriately allocating hospital resources
This study will enroll adults admitted to the ED with possible signs of HF While in the ED participants will undergo a digital heart sound recording procedure a medical record review blood collection and a brief cognitive assessment Five and 30 days following the ED visit participants will be contacted by phone or will be visited in the hospital by study staff Information will be collected on health status and unplanned hospital or ED visits that have occurred following the initial ED visit
This study will enroll adults admitted to the ED with possible signs of HF While in the ED participants will undergo a digital heart sound recording procedure a medical record review blood collection and a brief cognitive assessment Five and 30 days following the ED visit participants will be contacted by phone or will be visited in the hospital by study staff Information will be collected on health status and unplanned hospital or ED visits that have occurred following the initial ED visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01 HL055459 | US NIH GrantContract | None | httpsreporternihgovquickSearchR01HL088459 |
| R01HL088459 | NIH | None | None |