Strain Echo in Acute Heart Failure

NCT ID: NCT02371642

Last Updated: 2016-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure

Keywords

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Echocardiography

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wayne State University

OTHER

Sponsor Role lead

Responsible Party

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Mark Favot, MD

Assistant Professor of Emergency Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Detroit Receiving Hospital

Detroit, Michigan, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Mark J Favot, M.D.

Role: CONTACT

Phone: 313-966-1020

Email: [email protected]

Laura Gowland, RDCS

Role: CONTACT

Phone: 313-966-1020

Email: [email protected]

Facility Contacts

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Lauren Weber, MS

Role: primary

Other Identifiers

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unsponsored

Identifier Type: -

Identifier Source: org_study_id