Heart FailureStrain EchoNCT02371642
Strain Echo in Acute Heart Failure
An observational study of Heart Failure, run by Wayne State University at 1 site in United States.
Trial summary
The purpose of this project is to evaluate the utility of left ventricular strain as part of the assessment of patients in the emergency department with acute heart failure (HF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Jan 2017
- 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: Eligible subjects will be recruited in the emergency department (ED) of Detroit Receiving Hospital (DRH). The DRH ED has research team coverage 24 hours a day, 7 days a week and existing research personnel will be specifically trained to assist with subject identification for this protocol. We will also utilize resident physicians who are on ED based ultrasound and critical care rotations to help identify potential subjects and ensure that participants are captured early in their course and prior to initial treatment for acute HF. The ED will have 2 emergency ultrasound fellows beginning in July 2014 who will also assist with patient recruitment and performance of bedside echocardiograms for purposes of the study.
Who may be able to join
- 18 years of age or greater
- Ability for the patient to provide written informed consent
- Planned treatment with intravenous (IV) medications (diuretics, vasodilators, inotropes) for acute HF
Who cannot join
- Need for emergent, resuscitative intervention (e.g., cardiopulmonary resuscitation, endotracheal intubation)
- Rapid atrial fibrillation or other arrhythmia that requires IV rate or rhythm control
- Plans for emergent percutaneous coronary intervention (PCI) from the ED
- Pregnancy
- Incarceration
- history of cardiac transplant
- planned transfer to another institution
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Detroit Receiving Hospital
Detroit, Michigan, 48201
Lauren Weber, MS, 313-745-2955, lweber@med.wayne.edu
Mark J Favot, M.D.
About this study
Official title: The Utility of Strain Echocardiography in the Management of Acute Heart Failure
The purpose of this project is to evaluate the utility of left ventricular strain as part of the assessment of patients in the emergency department with acute heart failure (HF). The central hypothesis of the investigation is that left ventricular strain will prove to be a treatment response variable in patients with acute HF. Patients who are being treated for acute HF with intravenous (IV) vasoactive medications (diuretics, vasodilators, inotropes) will be eligible for enrollment. Patients who give written consent will receive a focused bedside echocardiogram within 30 minutes of the initiation of therapy for acute HF. Images that are captured during this echocardiogram will be interpreted by a blinded cardiologist offline. 23 hours after this initial focused echocardiogram a member of the study team will perform a follow-up focused echocardiogram, capturing the same images that will then be interpreted by a blinded cardiologist offline.
Offline analysis will be performed using a proprietary software package from General Electric called Automated Function Imaging (AFI). The AFI software will be used to calculate longitudinal strain of the left ventricle (LV). Regional and global strain values will be calculated for each focused echocardiogram for each subject. It is our hypothesis that LV strain will demonstrate improvements from the initial echocardiogram to the follow-up echocardiogram, unlike other echocardiographic indices in HF such as LV ejection fraction.
- Conditions
- Heart Failure
- Keywords
- Echocardiography
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
change in global longitudinal strain (GLS)
Measured: 23 hours
Secondary outcomes (1)
Readmission rate
Readmission for heart failure or other cardiovascular-related events
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Favot, MD, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02371642
- Sponsor's protocol ID
- unsponsored
- Acronym
- Strain Echo
- Status last verified
- Oct 2016
- First submitted
- 19 Feb 2015
- Last updated
- 1 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of Strain Echocardiography in the Management of Acute Heart Failure
- ClinicalTrials.gov ID
- NCT02371642
- Acronym / sponsor ID
- Strain Echo / unsponsored
- Conditions
- Heart Failure
- Keywords
- Echocardiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2017 (estimated)
- First posted
- 25 Feb 2015 (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.
The purpose of this project is to evaluate the utility of left ventricular strain as part of the assessment of patients in the emergency department with acute heart failure (HF). The central hypothesis of the investigation is that left ventricular strain will prove to be a treatment response variable in patients with acute HF. Patients who are being treated for acute HF with intravenous (IV) vasoactive medications (diuretics, vasodilators, inotropes) will be eligible for enrollment. Patients who give written consent will receive a focused bedside echocardiogram within 30 minutes of the initiation of therapy for acute HF. Images that are captured during this echocardiogram will be interpreted by a blinded cardiologist offline. 23 hours after this initial focused echocardiogram a member of the study team will perform a follow-up focused echocardiogram, capturing the same images that will then be interpreted by a blinded cardiologist offline.
Offline analysis will be performed using a proprietary software package from General Electric called Automated Function Imaging (AFI). The AFI software will be used to calculate longitudinal strain of the left ventricle (LV). Regional and global strain values will be calculated for each focused echocardiogram for each subject. It is our hypothesis that LV strain will demonstrate improvements from the initial echocardiogram to the follow-up echocardiogram, unlike other echocardiographic indices in HF such as LV ejection fraction.
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
- Eligible subjects will be recruited in the emergency department (ED) of Detroit Receiving Hospital (DRH). The DRH ED has research team coverage 24 hours a day, 7 days a week and existing research personnel will be specifically trained to assist with subject identification for this protocol. We will also utilize resident physicians who are on ED based ultrasound and critical care rotations to help identify potential subjects and ensure that participants are captured early in their course and prior to initial treatment for acute HF. The ED will have 2 emergency ultrasound fellows beginning in July 2014 who will also assist with patient recruitment and performance of bedside echocardiograms for purposes of the study.
Key inclusion criteria (3 listed)
- 18 years of age or greater
- Ability for the patient to provide written informed consent
- Planned treatment with intravenous (IV) medications (diuretics, vasodilators, inotropes) for acute HF
Key exclusion criteria (7 listed)
- Need for emergent, resuscitative intervention (e.g., cardiopulmonary resuscitation, endotracheal intubation)
- Rapid atrial fibrillation or other arrhythmia that requires IV rate or rhythm control
- Plans for emergent percutaneous coronary intervention (PCI) from the ED
- Pregnancy
- Incarceration
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
change in global longitudinal strain (GLS)
Time frame: 23 hours
1 secondary outcome
Readmission rate
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2016.
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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.
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 Heart Failure, run by Wayne State 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 7 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: status not confirmed, as of the sponsor's last update on 1 Nov 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark J Favot, M.D. (313-966-1020, mfavot@med.wayne.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in global longitudinal strain (GLS) (time frame: 23 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Nov 2016.