Identifying High- and Low-Risk Heart Failure Patients in the Emergency Department (The Stratify Study)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Cincinnati
Information provided by (Responsible Party):
Alan Storrow, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00508638
First received: July 26, 2007
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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.


Condition
Cardiovascular Diseases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improving Heart Failure Risk Stratification in the ED

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Information collected from participants while in the hospital, including a digital heart sound recording procedure, a medical record review, blood collection, and a brief cognitive assessment [ Time Frame: Measured while participants are in the hospital ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood


Estimated Enrollment: 1200
Study Start Date: May 2007
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

This will be a convenience sample of patients presenting to the emergency department for care.

Criteria

Inclusion Criteria:

  • Admitted to the adult ED with difficulty breathing, peripheral edema, or fatigue
  • Meets Framingham criteria for congestive heart failure
  • Willing and able to give informed consent; this will be determined based on participants' ability to remain in a conscious state, ability to remain awake, ability to ask questions about the study or answer questions that are asked, and ability to date and sign a consent form.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00508638

Locations
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267-0769
Sponsors and Collaborators
Vanderbilt University
University of Cincinnati
Investigators
Principal Investigator: Alan B. Storrow, MD Vanderbilt University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alan Storrow, Vice Chairman for Research and Academic Affairs, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00508638     History of Changes
Other Study ID Numbers: 508, R01HL088459, R01 HL055459
Study First Received: July 26, 2007
Last Updated: February 6, 2014
Health Authority: United States: Federal Government

Keywords provided by Vanderbilt University:
Heart Failure

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Failure
Heart Diseases

ClinicalTrials.gov processed this record on September 22, 2014