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

Lantheus Medical Imaging

Status and phase: Completed; Phase 4

Conditions: Ventricular Ejection Fraction

Treatments: Drug: Definity® Vial for (Perflutren Lipid Microsphere) Injectable Suspension

Study type: Interventional

Funder types: Industry

Identifiers

NCT00401687

DMP 115-412

Details and patient eligibility

About

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).

Enrollment: 131 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)