DMP115 in Patients With an Ejection Fraction Between 25%-40% to Evaluate the Use of Contrast Echocardiography to Assess Heart Function

A Multicenter, Phase IV Study to Evaluate the Ability of Definity® Enhanced Versus Unenhanced Echocardiography to Improve the Accuracy and Reproducibility of Left Ventricular Ejection Fraction When Compared to Cardiac Magnetic Resonance Imaging

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00401687

Enrollment

131

Registered

2006-11-20

Start date

2006-07-31

Completion date

2008-04-30

Last updated

2011-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventricular Ejection Fraction

Keywords

Reduced Heart Function

Brief summary

The purpose of this clinical research study is to demonstrate the ability of Definity® enhanced versus unenhanced cardiac ultrasound to improve the accuracy and reproducibility of left ventricular ejection fraction (EF) when compared to magnetic resonance imaging (MRI).

Interventions

DRUGDefinity® Vial for (Perflutren Lipid Microsphere) Injectable Suspension

The intervention for this study was that all patients received a slow bolus injection of diluted DEFINITY during the contrast-enhanced imaging study.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult subjects 18 years of age or older * Have a documented EF value ranging from 25% to 40% * Have been scheduled to undergo or have undergone a cardiac MRI study

Exclusion criteria

* Severe valvular dysfunction * Inability to remain supine for 30 minutes

Design outcomes

Primary

Measure	Time frame
Demonstrate the ability of Definity® enhanced versus unenhanced echocardiography to improve the accuracy of left ventricular ejection fraction when compared to cardiac magnetic resonance imaging (MRI) in a blinded assessment	Following the completion of patient enrollment when the images (ultrasound and MR) were evaluated independently by three blinded readers.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026