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

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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)

Trial contacts and locations

10

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Data sourced from clinicaltrials.gov

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