CompletedPhase 4

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

United States131 participantsStarted 2006-07

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Following the completion of patient enrollment when the images (ultrasound and MR) were evaluated independently by three blinded readers.

Trial details

NCT IDNCT00401687

SponsorLantheus Medical Imaging

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-06

View on ClinicalTrials.gov More Ventricular Ejection Fraction trials