Strain Echo in Acute Heart Failure

• Conditions: Heart Failure

• Registration Number: NCT02371642
• Lead Sponsor: Wayne State University

Brief 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). 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

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-02-19
• Study First Submitted QC: 2015-02-24
• Study First Posted: 2015-02-25
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-31
• Last Update Posted: 2016-11-01
• Primary Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
change in global longitudinal strain (GLS)	23 hours

Secondary Outcome Measures

Name	Time	Method
Readmission rate	30 days	Readmission for heart failure or other cardiovascular-related events

Trial Locations

Locations (1)

Detroit Receiving Hospital; 🇺🇸 Detroit, Michigan, United States