DEF-315 Better Accuracy in Ejection Fraction (EF) Assessment With DEFINITY

Cardiac Disease Clinical Trial

— BENEFIT2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03719612
• Other study ID #: DEF-315
• Status: Completed
• Phase: Phase 3
• Start date: December 28, 2018
• Est. completion date: January 9, 2020

Study information

• Verified date: November 2019
• Source: Lantheus Medical Imaging
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: January 9, 2020
• Est. primary completion date: January 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases

Intervention

Drug:
• DEFINITY®
All subjects will receive a single dose of DEFINITY®

Locations

Country	Name	City	State
United States	Indiana University	Bloomington	Indiana
United States	Northwestern Medical Group	Chicago	Illinois
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	Mercy Unit Hospital	Coon Rapids	Minnesota
United States	Duke University Medical Center	Durham	North Carolina
United States	Cedars Sinai	Los Angeles	California
United States	University of Oklahoma	Oklahoma City	Oklahoma
United States	University of California-Irvine	Orange	California
United States	Baptist Hospital	Paducah	Kentucky
United States	Albert Einstein Medical Center	Philadelphia	Pennsylvania
United States	Oregon Health and Sciences University	Portland	Oregon
United States	UC San Diego	San Diego	California
United States	Baylor Scott White Research Institute	Temple	Texas
United States	Banner University of Arizona Medical Center	Tucson	Arizona
United States	Alfieri Cardiology	Wilmington	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
Lantheus Medical Imaging	Syneos Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute Value of LVEF Percentage Differences From CMR by Blinded Reader	Demonstrate improvement in accuracy in left ventricular ejection fraction (LVEF) assessment using DEFINITY® contrast-enhanced over unenhanced echocardiography by comparing LVEF percentage differences from CMR measured by 3 independent blinded image readers.	Up to 30 days between day of echocardiograms and CMR imaging
Secondary	Secondary Objective 1: Absolute Value of LVEF Percentage Differences From CMR by Blinded Reader for Sub-optimal Echocardiograms	Demonstrate improvement in accuracy in left ventricular ejection fraction (LVEF) assessment using DEFINITY® contrast-enhanced over unenhanced echocardiography in subjects with suboptimal echocardiograms by comparing LVEF percentage differences from CMR measured by 3 independent blinded readers.	Up to 30 days between day of echocardiogram and CMR imaging
Secondary	Secondary Objective 2: Absolute Value LVEF Percentage Differences From CMR Between Blinded Readers	Demonstrate a reduction in inter-reader variability for the assessment of left ventricular ejection fraction using DEFINITY® contrast-enhanced versus unenhanced echocardiography by comparing LVEF percentage differences from CMR between 3 independent blinded readers.	Up to 30 days between day of echocardiograms and CMR imaging
Secondary	Secondary Objective 3: Absolute Value End-diastolic and Systolic Volume Differences From CMR Between Blinded Readers	Demonstrate a reduction in inter-reader variability for the assessment of end-diastolic/systolic volumes using DEFINITY® contrast-enhanced versus unenhanced echocardiography by comparing end-diastolic and systolic volume differences from CMR between 3 independent blinded readers.	Up to 30 days between day of echocardiogram and CMR imaging
Secondary	Secondary Objective 4: Absolute Value of LVEF Percentage Differences From CMR Between Readers for Sub-optimal Echocardiograms	Demonstrate a reduction in inter-reader variability for the assessment of left ventricular ejection fraction using DEFINITY® contrast-enhanced versus unenhanced echocardiography by comparing LVEF percentage differences from CMR between 3 independent blinded readers in subjects with suboptimal echocardiograms.	Up to 30 days between day of echocardiograms and CMR imaging
Secondary	Secondary Objective 5: Absolute Value End-diastolic and Systolic Volume Differences From CMR Between Blinded Readers for Suboptimal Echocardiograms	Demonstrate a reduction in inter-reader variability for the assessment of end-diastolic/systolic volumes using DEFINITY® contrast-enhanced versus unenhanced echocardiography by comparing end-diastolic and systolic volume differences from CMR between 3 independent blinded readers in subjects with suboptimal echocardiograms.	Up to 30 days between day of echocardiograms and CMR imaging