NCT02371642

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 25, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Last Updated

November 1, 2016

Status Verified

October 1, 2016

Enrollment Period

2 years

First QC Date

February 19, 2015

Last Update Submit

October 31, 2016

Conditions

Heart Failure

Keywords

Echocardiography

Outcome Measures

Primary Outcomes (1)

  • change in global longitudinal strain (GLS)

    23 hours

Secondary Outcomes (1)

  • Readmission rate

    30 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Detroit Receiving Hospital

Detroit, Michigan, 48201, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Mark J Favot, M.D.

CONTACT

313-966-1020mfavot@med.wayne.edu

Laura Gowland, RDCS

CONTACT

313-966-1020lgowland@med.wayne.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Emergency Medicine

Study Record Dates

First Submitted

February 19, 2015

First Posted

February 25, 2015

Study Start

January 1, 2015

Primary Completion

January 1, 2017

Last Updated

November 1, 2016

Record last verified: 2016-10

Locations

US(1)