Strain Echo in Acute Heart Failure

Heart Failure Clinical Trial

— Strain Echo  

Official title:

The Utility of Strain Echocardiography in the Management of Acute Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02371642
• Other study ID #: unsponsored
• Status: Recruiting
• Phase: N/A
• First received: February 19, 2015
• Last updated: October 31, 2016
• Start date: January 2015

Study information

• Verified date: October 2016
• Source: Wayne State University
• Contact: Mark J Favot, M.D.
• Phone: 313-966-1020
• Email: mfavot[@]med.wayne.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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). 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
United States	Detroit Receiving Hospital	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in global longitudinal strain (GLS)		23 hours	No
Secondary	Readmission rate	Readmission for heart failure or other cardiovascular-related events	30 days	No