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DEF-315 Better Accuracy in Ejection Fraction (EF) Assessment With DEFINITY (BENEFIT2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03719612
Recruitment Status : Completed
First Posted : October 25, 2018
Results First Posted : January 7, 2021
Last Update Posted : January 28, 2021
Sponsor:
Collaborator:
Syneos Health
Information provided by (Responsible Party):
Lantheus Medical Imaging

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.

Condition or disease Intervention/treatment Phase
Cardiac Disease Drug: DEFINITY® Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : December 28, 2018
Actual Primary Completion Date : January 9, 2020
Actual Study Completion Date : January 9, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Perflutren

Arm Intervention/treatment
Experimental: DEFINITY®
Each patient will undergo an unenhanced ultrasound examination and a DEFINITY® contrast-enhanced ultrasound
Drug: DEFINITY®
All subjects will receive a single dose of DEFINITY®




Primary Outcome Measures :
  1. Absolute Value of LVEF Percentage Differences From CMR by Blinded Reader [ Time Frame: Up to 30 days between day of echocardiograms and CMR imaging ]
    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.


Secondary Outcome Measures :
  1. Secondary Objective 1: Absolute Value of LVEF Percentage Differences From CMR by Blinded Reader for Sub-optimal Echocardiograms [ Time Frame: Up to 30 days between day of echocardiogram and CMR imaging ]
    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.

  2. Secondary Objective 2: Absolute Value LVEF Percentage Differences From CMR Between Blinded Readers [ Time Frame: Up to 30 days between day of echocardiograms and CMR imaging ]
    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.

  3. Secondary Objective 3: Absolute Value End-diastolic and Systolic Volume Differences From CMR Between Blinded Readers [ Time Frame: Up to 30 days between day of echocardiogram and CMR imaging ]
    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.

  4. Secondary Objective 4: Absolute Value of LVEF Percentage Differences From CMR Between Readers for Sub-optimal Echocardiograms [ Time Frame: Up to 30 days between day of echocardiograms and CMR imaging ]
    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.

  5. Secondary Objective 5: Absolute Value End-diastolic and Systolic Volume Differences From CMR Between Blinded Readers for Suboptimal Echocardiograms [ Time Frame: Up to 30 days between day of echocardiograms and CMR imaging ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03719612


Locations
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United States, Arizona
Banner University of Arizona Medical Center
Tucson, Arizona, United States, 85724
United States, California
Cedars Sinai
Los Angeles, California, United States, 90048
University of California-Irvine
Orange, California, United States, 92868
UC San Diego
San Diego, California, United States, 92037
United States, Delaware
Alfieri Cardiology
Wilmington, Delaware, United States, 19803
United States, Illinois
Northwestern Medical Group
Chicago, Illinois, United States, 60611
United States, Indiana
Indiana University
Bloomington, Indiana, United States, 46202
United States, Kentucky
Baptist Hospital
Paducah, Kentucky, United States, 42003
United States, Minnesota
Mercy Unit Hospital
Coon Rapids, Minnesota, United States, 55433
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219
United States, Oklahoma
University of Oklahoma
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Oregon Health and Sciences University
Portland, Oregon, United States, 97240
United States, Pennsylvania
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19412
United States, Texas
Baylor Scott White Research Institute
Temple, Texas, United States, 76501
Sponsors and Collaborators
Lantheus Medical Imaging
Syneos Health
  Study Documents (Full-Text)

Documents provided by Lantheus Medical Imaging:
Study Protocol  [PDF] August 15, 2018
Statistical Analysis Plan  [PDF] May 31, 2019

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Responsible Party: Lantheus Medical Imaging
ClinicalTrials.gov Identifier: NCT03719612    
Other Study ID Numbers: DEF-315
First Posted: October 25, 2018    Key Record Dates
Results First Posted: January 7, 2021
Last Update Posted: January 28, 2021
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lantheus Medical Imaging:
Left Ventricular Ejection Fraction
DEFINITY®
Enhanced Echocardiogram
Cardiac Magnetic Resonance
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases