Clinical trial NCT03719612: DEF-315 Better Accuracy in Ejection Fraction (EF) Assessment With DEFINITY
Official title: A Phase III, Open-Label, Multicenter Trial to Evaluate Ejection Fraction, End-Diastolic and End-Systolic Volumes, by Unenhanced and DEFINITY®-Enhanced 2D-Echo and Magnetic Resonance Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiac Disease
Keywords: Left Ventricular Ejection Fraction
DEFINITY®
Enhanced Echocardiogram
Cardiac Magnetic Resonance
Lead sponsor: Lantheus Medical Imaging
Sponsor class: INDUSTRY
Collaborators: name: Syneos Health
First posted: 2018-10-25
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a Phase 3, prospective, open-label, multicenter study to evaluate Left Ventricular Ejection Fraction (LVEF) measurement accuracy and reproducibility of DEFINITY® contrast-enhanced and unenhanced echocardiography as compared with non-contrast cardiac magnetic resonance imaging (CMR) used as the truth standard.


Eligibility criteria: Inclusion Criteria:

1. Men and women ≥ 18 years of age in sinus rhythm
2. Able to communicate effectively with trial personnel
3. LVEF measurements obtained via 2D Echo with or without contrast obtained within 6 months prior to enrollment (Day 0)
4. Has provided signed informed consent after receiving a verbal and written explanation of this clinical trial

Exclusion Criteria:

1. Female subjects who are pregnant or lactating. All women of child bearing potential \[WOCBP\] must have a negative urine pregnancy test at screening regardless of contraceptive use history.
2. Women of child-bearing potential are excluded unless they:

   1. are post-menopausal defined as amenorrhea ≥ 12 consecutive months, OR
   2. have undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy), OR
   3. have been using an adequate and medically approved method of contraception to avoid pregnancy for at least 1 month prior to DEFINITY® dose administration and be willing to continue using the same method for the duration of the study.
3. Current illness or pathology that would prevent undergoing investigational product administration due to a significant safety risk to the patient.
4. Uncontrolled arterial hypertension (defined as systolic blood pressure ≥ 200 mmHg or diastolic blood pressure ≥ 110 mmHg) or arterial hypotension (defined as systolic blood pressure ≤ 90 mmHg).
5. Unstable cardiovascular status defined as:

   1. myocardial infarction or unstable angina pectoris within 6 months prior to enrollment/DEFINITY® dose administration day
   2. transient ischemic attack or stroke within 3 months prior to DEFINITY® dose administration
   3. symptomatic valvular heart disease or moderate to severe stenotic valvular heart disease
   4. clinically significant congenital heart defects
   5. current uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise
   6. acute pulmonary embolus or pulmonary infarction
   7. acute myocarditis or pericarditis
   8. acute aortic dissection
   9. atrial fibrillation
6. any major surgery within 4 weeks prior to screening
7. known contraindications to undergoing CMR (e.g. implanted pacemakers, cardioverter, defibrillators) or claustrophobia
8. participation in any investigational drug, device, or placebo study within 30 days prior to screening
9. known hypersensitivity to perflutren, or any of the excipients in DEFINITY®
10. prisoners or those who are subject to compulsory detention or involuntary incarceration for treatment of either a psychiatric or physical illness (e.g., infectious disease).

Primary outcomes:
measure: Absolute Value of LVEF Percentage Differences From CMR by Blinded Reader
timeFrame: Up to 30 days between day of echocardiograms and CMR imaging
Secondary outcomes:
measure: Secondary Objective 1: Absolute Value of LVEF Percentage Differences From CMR by Blinded Reader for Sub-optimal Echocardiograms
timeFrame: Up to 30 days between day of echocardiogram and CMR imaging
measure: Secondary Objective 2: Absolute Value LVEF Percentage Differences From CMR Between Blinded Readers
timeFrame: Up to 30 days between day of echocardiograms and CMR imaging
measure: Secondary Objective 3: Absolute Value End-diastolic and Systolic Volume Differences From CMR Between Blinded Readers
timeFrame: Up to 30 days between day of echocardiogram and CMR imaging
measure: Secondary Objective 4: Absolute Value of LVEF Percentage Differences From CMR Between Readers for Sub-optimal Echocardiograms
timeFrame: Up to 30 days between day of echocardiograms and CMR imaging
measure: Secondary Objective 5: Absolute Value End-diastolic and Systolic Volume Differences From CMR Between Blinded Readers for Suboptimal Echocardiograms
timeFrame: Up to 30 days between day of echocardiograms and CMR imaging
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Banner University of Arizona Medical Center
state: Arizona
city: Los Angeles
country: United States
facility: Cedars Sinai
state: California
city: Orange
country: United States
facility: University of California-Irvine
state: California
city: San Diego
country: United States
facility: UC San Diego
state: California
city: Wilmington
country: United States
facility: Alfieri Cardiology
state: Delaware
city: Chicago
country: United States
facility: Northwestern Medical Group
state: Illinois
city: Bloomington
country: United States
facility: Indiana University
state: Indiana
city: Paducah
country: United States
facility: Baptist Hospital
state: Kentucky
city: Coon Rapids
country: United States
facility: Mercy Unit Hospital
state: Minnesota
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health and Sciences University
state: Oregon
city: Philadelphia
country: United States
facility: Albert Einstein Medical Center
state: Pennsylvania
city: Temple
country: United States
facility: Baylor Scott White Research Institute
state: Texas
Study officials:
References: