Cardiovascular DiseasesStratifyNCT00508638
Identifying High- and Low-Risk Heart Failure Patients in the Emergency Department (The Stratify Study)
An observational study of Cardiovascular Diseases, run by Vanderbilt University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- How many people
- 1,033 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This will be a convenience sample of patients presenting to the emergency department for care.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati
Cincinnati, Ohio, 45267-0769
About this study
Official title: Improving Heart Failure Risk Stratification in the ED
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.
Read the 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.
- Conditions
- Cardiovascular Diseases
- Keywords
- Heart Failure
- Medical subject headings
- Cardiovascular Diseases, Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Measured while participants are in the hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2007 (estimated)
- Study startMay 2007
- Primary completionDec 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,033 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alan Storrow, Vanderbilt University
- Investigators
- Alan B. Storrow, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00508638
- Sponsor's protocol ID
- 508
- Other IDs
- R01HL088459, R01 HL055459
- Acronym
- Stratify
- Status last verified
- Apr 2017
- First submitted
- 26 Jul 2007
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Collins SP, Hart KW, Lindsell CJ, Fermann GJ, Weintraub NL, Miller KF, Roll SN, Sperling MI, Sawyer DB, Storrow AB. Elevated urinary neutrophil gelatinase-associated lipocalcin after acute heart failure treatment is associated with worsening renal function and adverse events. Eur J Heart Fail. 2012 Sep;14(9):1020-9. doi: 10.1093/eurjhf/hfs087. Epub 2012 Jun 25.
PubMed 22733980Collins SP, Lindsell CJ, Storrow AB, Fermann GJ, Levy PD, Pang PS, Weintraub N, Frank Peacock W, Sawyer DB, Gheorghiade M. Early changes in clinical characteristics after emergency department therapy for acute heart failure syndromes: identifying patients who do not respond to standard therapy. Heart Fail Rev. 2012 May;17(3):387-94. doi: 10.1007/s10741-011-9294-7.
PubMed 22160814Pang PS, Collins SP, Storrow AB. Letter by Pang et al regarding article, "Early deaths in heart failure patients discharged from the emergency department: a population-based analysis". Circ Heart Fail. 2010 Jul;3(4):e22; author reply e23. doi: 10.1161/CIRCHEARTFAILURE.110.945865. No abstract available.
PubMed 20647481Collins SP, Lindsell CJ, Yealy DM, Maron DJ, Naftilan AJ, McPherson JA, Storrow AB. A comparison of criterion standard methods to diagnose acute heart failure. Congest Heart Fail. 2012 Sep-Oct;18(5):262-71. doi: 10.1111/j.1751-7133.2012.00288.x. Epub 2012 Apr 4.
PubMed 22994440Doering A, Jenkins CA, Storrow AB, Lindenfeld J, Fermann GJ, Miller KF, Sperling M, Collins SP. Markers of diuretic resistance in emergency department patients with acute heart failure. Int J Emerg Med. 2017 Dec;10(1):17. doi: 10.1186/s12245-017-0143-x. Epub 2017 May 8.
PubMed 28484958Collins SP, Jenkins CA, Harrell FE Jr, Liu D, Miller KF, Lindsell CJ, Naftilan AJ, McPherson JA, Maron DJ, Sawyer DB, Weintraub NL, Fermann GJ, Roll SK, Sperling M, Storrow AB. Identification of Emergency Department Patients With Acute Heart Failure at Low Risk for 30-Day Adverse Events: The STRATIFY Decision Tool. JACC Heart Fail. 2015 Oct;3(10):737-47. doi: 10.1016/j.jchf.2015.05.007.
PubMed 26449993Collins SP, Lindsell CJ, Jenkins CA, Harrell FE, Fermann GJ, Miller KF, Roll SN, Sperling MI, Maron DJ, Naftilan AJ, McPherson JA, Weintraub NL, Sawyer DB, Storrow AB. Risk stratification in acute heart failure: rationale and design of the STRATIFY and DECIDE studies. Am Heart J. 2012 Dec;164(6):825-34. doi: 10.1016/j.ahj.2012.07.033. Epub 2012 Oct 29.
PubMed 23194482
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Heart Failure Risk Stratification in the ED
- ClinicalTrials.gov ID
- NCT00508638
- Acronym / sponsor ID
- Stratify / 508
- Conditions
- Cardiovascular Diseases
- Keywords
- Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,033 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Cincinnati
- Study start
- May 2007
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 30 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This will be a convenience sample of patients presenting to the emergency department for care.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2017.
- Background: PubMed 22733980Collins SP, Hart KW, Lindsell CJ, Fermann GJ, Weintraub NL, Miller KF, Roll SN, Sperling MI, Sawyer DB, Storrow AB. Elevated urinary neutrophil gelatinase-associated lipocalcin after acute heart failure treatment is associated with worsening renal function and adverse events. Eur J Heart Fail. 2012 Sep;14(9):1020-9. doi: 10.1093/eurjhf/hfs087. Epub 2012 Jun 25.
- Background: PubMed 22160814Collins SP, Lindsell CJ, Storrow AB, Fermann GJ, Levy PD, Pang PS, Weintraub N, Frank Peacock W, Sawyer DB, Gheorghiade M. Early changes in clinical characteristics after emergency department therapy for acute heart failure syndromes: identifying patients who do not respond to standard therapy. Heart Fail Rev. 2012 May;17(3):387-94. doi: 10.1007/s10741-011-9294-7.
- Background: PubMed 20647481Pang PS, Collins SP, Storrow AB. Letter by Pang et al regarding article, "Early deaths in heart failure patients discharged from the emergency department: a population-based analysis". Circ Heart Fail. 2010 Jul;3(4):e22; author reply e23. doi: 10.1161/CIRCHEARTFAILURE.110.945865. No abstract available.
- Results publication: PubMed 22994440Collins SP, Lindsell CJ, Yealy DM, Maron DJ, Naftilan AJ, McPherson JA, Storrow AB. A comparison of criterion standard methods to diagnose acute heart failure. Congest Heart Fail. 2012 Sep-Oct;18(5):262-71. doi: 10.1111/j.1751-7133.2012.00288.x. Epub 2012 Apr 4.
- Derived from this study: PubMed 28484958Doering A, Jenkins CA, Storrow AB, Lindenfeld J, Fermann GJ, Miller KF, Sperling M, Collins SP. Markers of diuretic resistance in emergency department patients with acute heart failure. Int J Emerg Med. 2017 Dec;10(1):17. doi: 10.1186/s12245-017-0143-x. Epub 2017 May 8.
- Derived from this study: PubMed 26449993Collins SP, Jenkins CA, Harrell FE Jr, Liu D, Miller KF, Lindsell CJ, Naftilan AJ, McPherson JA, Maron DJ, Sawyer DB, Weintraub NL, Fermann GJ, Roll SK, Sperling M, Storrow AB. Identification of Emergency Department Patients With Acute Heart Failure at Low Risk for 30-Day Adverse Events: The STRATIFY Decision Tool. JACC Heart Fail. 2015 Oct;3(10):737-47. doi: 10.1016/j.jchf.2015.05.007.
- Derived from this study: PubMed 23194482Collins SP, Lindsell CJ, Jenkins CA, Harrell FE, Fermann GJ, Miller KF, Roll SN, Sperling MI, Maron DJ, Naftilan AJ, McPherson JA, Weintraub NL, Sawyer DB, Storrow AB. Risk stratification in acute heart failure: rationale and design of the STRATIFY and DECIDE studies. Am Heart J. 2012 Dec;164(6):825-34. doi: 10.1016/j.ahj.2012.07.033. Epub 2012 Oct 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alan B. Storrow, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00508638, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2017.